## Protocol Section
### Identification Module
**NCT ID:** NCT03449979

**Acronym:** SSDE

**Brief Title:** Single Session of tACS in a Depressive Episode

**Official Title:** Rational Optimization of tACS for Targeting Thalamo-Cortical Oscillations (Experiment 3)

#### Organization Study ID Info
**ID:** 16-1911b
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
#### Secondary ID Infos
**ID:** R01MH101547
**Link:** https://reporter.nih.gov/quickSearch/R01MH101547
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2019-08-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-06-04

**Type:** ACTUAL

**Last Update Submit Date:** 2020-05-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-08-16

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-06-04

**Type:** ACTUAL

**Results First Submit Date:** 2020-05-18

**Results First Submit QC Date:** 2020-05-18

#### Start Date
**Date:** 2018-09-19

**Type:** ACTUAL

**Status Verified Date:** 2019-09

#### Study First Post Date
**Date:** 2018-02-28
**Type:** ACTUAL
**Study First Submit Date:** 2018-02-15
**Study First Submit QC Date:** 2018-02-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Mental Health (NIMH)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of North Carolina, Chapel Hill

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Purpose: Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on healthy participants and participants with mood disorders.

Participants: 40 males and females, ages 18-65, with depressed mood; 40 healthy males and females, ages 18-65, free of neurological or psychiatric conditions.

Procedures: This is a single visit study with two stimulation conditions (tACS and sham tACS). The session will begin with clinical assessments (including confirmation of diagnosis), followed by an interactive EEG task, then a 7 minute resting state EEG (2 minutes eyes closed, 5 minutes eyes open), followed by the stimulation session (40 minutes of tACS or sham tACS), followed by an additional 5 minute resting state EEG. The stimulation will involved 40 minutes of transcranial alternating current stimulation, 2 mA in amplitude and at individualized alpha frequency (determined by the 2 minutes eyes closed EEG recording; between 8 and 12Hz).

**Detailed Description:** Participants will report for a study visit and will review and sign a consent form.

Participants will complete several clinical assessments and also take a urine drug test and urine pregnancy test (if applicable). Eligibility will be re-assessed by the investigators before the participant moves on to the next phase.

If the participant still qualifies, the participant will first be fitted with two 5x5cm electrodes placed over F3/F4 (10-20 measurement system) and one 5x7cm electrode placed over Cz. In addition, the participant will have a 128-channel EEG net placed on their head. Participants will provide a saliva sample to assess for brain-derived neurotrophic factor (BDNF), which may affect how the participant's brain responds to stimulation. Once the participant is fitted with this equipment, the participant will complete two interactive EEG tasks, then 2-minute resting state EEG with the participant's eyes closed, then a 5-minute resting state EEG with the participant's eyes open.

Following these recordings, participants will respond to additional questionnaires. Immediately following this, the participant will receive 40 minutes of stimulation (tACS or sham tACS). During this stimulation, participants will sit comfortably upright and awake.

After stimulation has completed, participants will respond to additional questionnaires. Once completed, participants will then complete an additional 5-minute resting state EEG with the participant's eyes open, as well as complete one of the additional interactive EEG tasks.

Finally, participants will respond to a blinding questionnaire to assess if the participant thought that the participant received stimulation. Once complete, the participant will leave. This session is estimated to last about 4 hours.

### Conditions Module

**Conditions:**

- Depression

- Major Depressive Disorder

- Premenstrual Dysphoric Disorder

- Depressive Episode

**Keywords:**

- tACS

- transcranial alternating current stimulation

- stimulation

- heart rate variability

- electroencephalogram

- EEG

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This study recruits both participants currently experiencing a depressive episode (regardless of diagnosis) and those with no history of neurological or psychiatric illness. Randomization will occur in a 1:1 ratio for both of these groups, with half of each group receiving transcranial alternating current stimulation (tACS) at 10 Hz and the other half receiving placebo (or sham) stimulation.

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** This is a double-blind study, meaning that neither the participant nor the experimenter knows what kind of stimulation the participant is receiving. An unblinded monitor (separate from the staff that interacts with the participant) is responsible for creating the stimulation codes that run each session and for ensuring that these codes worked correctly.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 84

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

**Intervention Names:**

- Device: XCSITE100 Stimulator tACS

**Label:** alpha stimulation in participants in a depressive episode

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.

**Intervention Names:**

- Device: XCSITE100 Stimulator Sham

**Label:** sham stimulation in participants in a depressive episode

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

**Description:** Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

**Intervention Names:**

- Device: XCSITE100 Stimulator tACS

**Label:** alpha stimulation in healthy participants

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.

**Intervention Names:**

- Device: XCSITE100 Stimulator Sham

**Label:** sham stimulation in healthy participants

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- sham stimulation in healthy participants

- sham stimulation in participants in a depressive episode

**Description:** The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.

**Name:** XCSITE100 Stimulator Sham

**Other Names:**

- Sham tACS

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- alpha stimulation in healthy participants

- alpha stimulation in participants in a depressive episode

**Description:** Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.

**Name:** XCSITE100 Stimulator tACS

**Other Names:**

- tACS

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Fast Fourier transform is applied to 5 minutes of EEG data before and after intervention. Primary outcome is the difference in alpha frequency amplitude (8-12 Hz) in the left frontal cortex from baseline as a result of intervention.

**Measure:** Change in Alpha Frequency Electrical Activity in Left Frontal Cortex From Stimulation

**Time Frame:** 5 minute recording before and after intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria for individuals with depressed mood:

* Ages 18-65 years
* Hamilton Depression Rating Scale score \>8
* Capacity to understand all relevant risks and potential benefits of the study (informed consent)
* Low suicide risk which will be determined through the use of both the Structured Clinical Interview for the DSM-5 and by scoring less than 3 (0,1, or 2) in the Hamilton rating depression scale.
* Negative pregnancy test for female participants

Exclusion Criteria for individuals with depressed mood:

* DSM-5 diagnosis of alcohol of substance abuse (other than nicotine) within the 12 months
* DSM-5 diagnosis of alcohol or substance dependence (other than nicotine) within the last 12 months
* DSM-5 diagnosis of personality disorder
* Eating disorder (current or within the past 3 months)
* Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
* Neurological disorders, including but not limited to history of seizures (except childhood febrile seizures and electro-convulsive therapy (ECT) induced seizures), dementia, history of stroke, Parkinson's disease, multiple sclerosis, cerebral aneurysm.
* Medical or neurological illness (unstable cardiac disease, AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation
* History of traumatic brain injury, reoccurring seizures or later cognitive rehabilitation or causing cognitive sequelae
* History of childhood trauma (determined by the Childhood Trauma Questionnaire)
* Prior brain surgery
* Any brain devices/implants, including cochlear implants and aneurysm clips
* Co-morbid neurological condition (i.e. seizure disorder, brain tumor)
* Use of illicit drugs, confirmed by a drug test
* Non English speakers
* Pregnant or nursing females
* Current use of benzodiazepines or anti-epileptic drugs

Inclusion Criteria for healthy controls:

* Ages 18-65 years
* Hamilton Depression Rating Scale score ≤8
* Capacity to understand all relevant risks and potential benefits of the study (informed consent)
* Negative pregnancy test for female participants

Exclusion Criteria for healthy controls:

* History of major neurological or psychiatric illness, including epilepsy
* Medication use associated with neurological or psychiatric illnesses
* Currently undergoing counseling or psychotherapy treatment for depression, anxiety, eating disorders, PTSD or other behavioral conditions
* DSM-5 diagnosis of personality disorder
* First degree relative (parent, sibling, child) with major neurological or psychiatric illness
* Prior brain surgery
* Major head injury
* Any brain devices/implants (including cochlear implants and aneurysm clips)
* History of childhood trauma (determined by the Childhood Trauma Questionnaire)
* Use of illicit drugs, confirmed by a drug test
* Braids or other hair styling that prevents direct access to the scalp (if removal not possible)
* Skin allergies or very sensitive skin
* Non English speakers
* Pregnant or nursing females

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chapel Hill

**Country:** United States

**Facility:** University of North Carolina Chapel Hill

**State:** North Carolina

**Zip:** 27599

#### Overall Officials

**Official 1:**

**Affiliation:** UNC Chapel Hill

**Name:** Flavio Frohlich, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-04-29

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 856965

- Type Abbrev: Prot_SAP

- Upload Date: 2020-01-14T13:30

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000011293

- Term: Premenstrual Syndrome

- ID: D000008599

- Term: Menstruation Disturbances

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depressive Episode

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M7060

- Name: Depressive Disorder, Major

- Relevance: HIGH

- As Found: Major Depressive Disorder

- ID: M30514

- Name: Premenstrual Dysphoric Disorder

- Relevance: HIGH

- As Found: Premenstrual Dysphoric Disorder

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M14167

- Name: Premenstrual Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M11582

- Name: Menstruation Disturbances

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000065446

- Term: Premenstrual Dysphoric Disorder

- ID: D000003863

- Term: Depression

- ID: D000003866

- Term: Depressive Disorder

- ID: D000003865

- Term: Depressive Disorder, Major

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M16975

- Name: Triamcinolone Acetonide

- Relevance: LOW

- As Found: Unknown

- ID: M16974

- Name: Triamcinolone

- Relevance: LOW

- As Found: Unknown

- ID: M237966

- Name: Triamcinolone hexacetonide

- Relevance: LOW

- As Found: Unknown

- ID: M209573

- Name: Triamcinolone diacetate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Alpha Stimulation in Patients in a Depressive Episode

**Deaths Num At Risk:** 21

**Description:** Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.

**ID:** EG000

**Other Num Affected:** 12

**Other Num at Risk:** 21

**Serious Number At Risk:** 21

**Title:** Alpha Stimulation in Patients in a Depressive Episode

**Group ID:** EG001

**Title:** Sham Stimulation in Patients in a Depressive Episode

**Deaths Num At Risk:** 20

**Description:** Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.

XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.

**ID:** EG001

**Other Num Affected:** 7

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** Sham Stimulation in Patients in a Depressive Episode

**Group ID:** EG002

**Title:** Alpha Stimulation in Healthy Participants

**Deaths Num At Risk:** 21

**Description:** Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.

**ID:** EG002

**Other Num Affected:** 9

**Other Num at Risk:** 21

**Serious Number At Risk:** 21

**Title:** Alpha Stimulation in Healthy Participants

**Group ID:** EG003

**Title:** Sham Stimulation in Healthy Participants

**Deaths Num At Risk:** 22

**Description:** Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.

XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.

**ID:** EG003

**Other Num Affected:** 5

**Other Num at Risk:** 22

**Serious Number At Risk:** 22

**Title:** Sham Stimulation in Healthy Participants

**Frequency Threshold:** 0

#### Other Events

**Term:** Tingling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Flickering Lights

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Itching

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Burning sensation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Scalp pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Neck pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Time Frame:** Adverse events were collected over the 5 hours of the single session experiment

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 21

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 21

**Group ID:** BG003

**Value:** 22

**Group ID:** BG004

**Value:** 84

**Units:** Participants

### Group

**ID:** BG000

**Title:** Alpha Stimulation in Participants in a Depressive Episode

**Description:** Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.

### Group

**ID:** BG001

**Title:** Sham Stimulation in Participants in a Depressive Episode

**Description:** Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.

XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.

### Group

**ID:** BG002

**Title:** Alpha Stimulation in Healthy Participants

**Description:** Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.

### Group

**ID:** BG003

**Title:** Sham Stimulation in Healthy Participants

**Description:** Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.

XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.

### Group

**ID:** BG004

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.902

**Value:** 28.429

#### Measurement

**Group ID:** BG001

**Spread:** 12.227

**Value:** 27.65

#### Measurement

**Group ID:** BG002

**Spread:** 11.432

**Value:** 28.095

#### Measurement

**Group ID:** BG003

**Spread:** 12.133

**Value:** 27.182

#### Measurement

**Group ID:** BG004

**Spread:** 11.831

**Value:** 27.796

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 21

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 21

**Group ID:** BG003

**Value:** 22

**Group ID:** BG004

**Value:** 84

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 17

#### Measurement

**Group ID:** BG003

**Value:** 17

#### Measurement

**Group ID:** BG004

**Value:** 67

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Measurement

**Group ID:** BG004

**Value:** 17

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 21

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 21

**Group ID:** BG003

**Value:** 22

**Group ID:** BG004

**Value:** 84

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 2

#### Measurement

**Group ID:** BG004

**Value:** 9

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 14

#### Measurement

**Group ID:** BG003

**Value:** 17

#### Measurement

**Group ID:** BG004

**Value:** 70

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 3

#### Measurement

**Group ID:** BG004

**Value:** 5

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 21

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 21

**Group ID:** BG003

**Value:** 22

**Group ID:** BG004

**Value:** 84

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 7

#### Measurement

**Group ID:** BG004

**Value:** 13

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 4

#### Measurement

**Group ID:** BG004

**Value:** 12

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 13

#### Measurement

**Group ID:** BG003

**Value:** 10

#### Measurement

**Group ID:** BG004

**Value:** 54

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 5

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 21

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 21

**Group ID:** BG003

**Value:** 22

**Group ID:** BG004

**Value:** 84

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 21

#### Measurement

**Group ID:** BG003

**Value:** 22

#### Measurement

**Group ID:** BG004

**Value:** 84

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 21

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 21

**Group ID:** BG003

**Value:** 22

**Group ID:** BG004

**Value:** 84

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.088

**Value:** 0.789

#### Measurement

**Group ID:** BG001

**Spread:** 0.056

**Value:** 0.812

#### Measurement

**Group ID:** BG002

**Spread:** 0.076

**Value:** 0.826

#### Measurement

**Group ID:** BG003

**Spread:** 0.095

**Value:** 0.845

#### Measurement

**Group ID:** BG004

**Spread:** 0.081

**Value:** 0.818

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 21

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 21

**Group ID:** BG003

**Value:** 20

**Group ID:** BG004

**Value:** 82

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** One healthy control participant that received sham stimulation was excluded from analysis as we were unable to find an age and sex matched participant. One healthy control participant that received sham stimulation did not complete the study due to technical difficulties.
**Title:** Alpha oscillations in left frontal cortex before stimulation
**Unit of Measure:** microvolts
**Population Description:** One healthy control participant that received sham stimulation was excluded from analysis as we were unable to find an age and sex matched participant. One healthy control participant that received sham stimulation did not complete the study due to technical difficulties.
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** justin_riddle@med.unc.edu
**Organization:** University of North Carolina at Chapel Hill
**Phone:** 6617131602
**Title:** Justin Riddle, PhD
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Interaction in the effect of tACS on left frontal alpha oscillation in the depressed group. Two-way interaction of within-participant factor of before/after tACS and between-participant factor of alpha-tACS/placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0852
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** degrees of freedom = (1,39); F-statistic = 3.119
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Interaction in the effect of tACS on left frontal alpha oscillation in the healthy group. Two-way interaction of within-participant factor of before/after tACS and between-participant factor of alpha-tACS/placebo.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.6676
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** degrees of freedom = (1,39); F-statistic = 0.187
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Main effect of alpha-tACS on session (before and after) on left frontal alpha oscillations across both groups (healthy and patient).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.929
**P-Value Comment:** degrees of freedom = (1,41); F-statistic = 0.008
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Difference in alpha oscillations after versus before in the depressed cohort (one-tailed Student's t-test) with the hypothesis to decrease pathologically elevate left frontal alpha oscillations
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.1950
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** degrees of freedom = 20; t-statistic = -0.08789
**Statistical Method:** t-test, 1 sided
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Difference in alpha oscillations after versus before in the healthy cohort (one-tailed Student's t-test) run as a control analysis
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.8603
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** degrees of freedom = 20; t-statistic = 1.1117
**Statistical Method:** t-test, 1 sided
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.022
- **Upper Limit:** 
- **Value:** -0.005
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.023
- **Upper Limit:** 
- **Value:** 0.008
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.017
- **Upper Limit:** 
- **Value:** 0.004
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.022
- **Upper Limit:** 
- **Value:** 0.007
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Fast Fourier transform is applied to 5 minutes of EEG data before and after intervention. Primary outcome is the difference in alpha frequency amplitude (8-12 Hz) in the left frontal cortex from baseline as a result of intervention.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One of the healthy participants that received sham stimulation could not be age and sex matched, therefore, we did not analyze this participant.
**Reporting Status:** POSTED
**Time Frame:** 5 minute recording before and after intervention
**Title:** Change in Alpha Frequency Electrical Activity in Left Frontal Cortex From Stimulation
**Type:** PRIMARY
**Unit of Measure:** microvolts
##### Group
**Description:** Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
**ID:** OG000
**Title:** Alpha Stimulation in Participants in a Depressive Episode
##### Group
**Description:** Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.

XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
**ID:** OG001
**Title:** Sham Stimulation in Participants in a Depressive Episode
##### Group
**Description:** Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
**ID:** OG002
**Title:** Alpha Stimulation in Healthy Participants
##### Group
**Description:** Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.

XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
**ID:** OG003
**Title:** Sham Stimulation in Healthy Participants
### Participant Flow Module
#### Group
**Description:** Participants in a depressive episode will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
**ID:** FG000
**Title:** Alpha Stimulation in Participants in a Depressive Episode
#### Group
**Description:** Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to participants in a depressive episode is delivered using the XCSITE100 Stimulator Sham.

XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
**ID:** FG001
**Title:** Sham Stimulation in Participants in a Depressive Episode
#### Group
**Description:** Healthy participants will receive 2 mA of alternating current stimulation at individualized alpha stimulation (between 8 and 12 Hz; determined by an EEG recording prior to stimulation) for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.

XCSITE100 Stimulator tACS: Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
**ID:** FG002
**Title:** Alpha Stimulation in Healthy Participants
#### Group
**Description:** Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation to healthy participants is delivered using the XCSITE100 Stimulator Sham.

XCSITE100 Stimulator Sham: The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
**ID:** FG003
**Title:** Sham Stimulation in Healthy Participants
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Technical difficulty
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 22
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 21
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 1
**Has Results:** True