## Protocol Section
### Identification Module
**NCT ID:** NCT03663179

**Brief Title:** Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD)

**Official Title:** A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Adult ADHD

#### Organization Study ID Info
**ID:** 826586
#### Organization
**Class:** OTHER
**Full Name:** University of Pennsylvania
### Status Module
#### Completion Date
**Date:** 2020-01-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-05

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-03-31

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-10-28

**Type:** ACTUAL

**Results First Submit Date:** 2019-09-09

**Results First Submit QC Date:** 2019-10-24

#### Start Date
**Date:** 2017-01

**Type:** ACTUAL

**Status Verified Date:** 2022-08

#### Study First Post Date
**Date:** 2018-09-10
**Type:** ACTUAL
**Study First Submit Date:** 2018-08-02
**Study First Submit QC Date:** 2018-09-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Pennsylvania

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will test the effects of transcranial magnetic stimulation (TMS) on clinical measures of ADHD symptoms.

**Detailed Description:** Attention Deficit Hyperactivity Disorder (ADHD) is characterized by symptoms of impulsivity, inattention, and hyperactivity that emerge in childhood and frequently persist into adulthood. These symptoms are accompanied by deficits in cognitive control and risky decision making that can lead to negative psychosocial and health-related outcomes. With advances in the neuroimaging field, researchers are learning where and how self-control over decisions and behaviors is executed in the brain. This work points to the central role of neural activity in the dorsolateral prefrontal cortices (DLPFC) in self-control processes that contribute to healthy choices. Emerging evidence shows that activity in the prefrontal cortices and cognitive control circuits can be modulated using a noninvasive and safe intervention: repetitive TMS. This within-subject proof of concept study will investigate whether 20 sessions of TMS (versus sham stimulation) can enhance executive cognitive function in adults with ADHD.

### Conditions Module

**Conditions:**

- Attention Deficit Disorder With Hyperactivity (ADHD)

**Keywords:**

- ADHD

- TMS

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 32

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive 20 sessions of active TMS targeting the left DLPFC.

**Intervention Names:**

- Device: Transcranial Magnetic Stimulation (TMS)

**Label:** Active TMS

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive 20 sessions of sham TMS over the left DLPFC.

**Intervention Names:**

- Device: Sham Transcranial Magnetic Stimulation (Sham TMS)

**Label:** Sham TMS

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Active TMS

**Description:** A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).

**Name:** Transcranial Magnetic Stimulation (TMS)

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Sham TMS

**Description:** A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).

**Name:** Sham Transcranial Magnetic Stimulation (Sham TMS)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** ADHD symptoms will be assessed using the well-validated Conners Adult ADHD Rating Scale - Self-Report: Long Version (CAARS-S:L). The CAARS-S:L is a 66-item rating scale designed to assess ADHD symptoms in adults. The scale contains multiple subscales to assess Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) specified ADHD criteria as well as other facets of ADHD such as inattention/memory problems, hyperactivity/restlessness, impulsivity/emotionality, and problems with self-concept. Subscale results are converted to T-scores (range: 25-90), where 50 is the standardized population mean and every 10 points indicates one standard deviation from the mean. Higher values generally indicate more difficulties with ADHD symptoms. This measure will be administered at baseline at at the end of 4 weeks of treatment. The primary outcome will be the change from baseline to week 4.

**Measure:** Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms)

**Time Frame:** Baseline and week 4

#### Secondary Outcomes

**Description:** The Conners Continuous Performance Task (Conners CPT) will be administered and baseline and weekly during the treatment period to assess sustained attention. In this task, participants are shown a series of letters on a computer screen and are asked to press the spacebar in response to all letters except for the letter X. The primary outcome for the Conners CPT is the change in number of commission errors (e.g., false positives) from baseline to week 4.

**Measure:** Change in Performance on Conners Continuous Performance Task (Sustained Attention)

**Time Frame:** Baseline and week 4

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Eligible participants will be:

1. Healthy males and females who are between 18 and 65 years of age with an ADHD diagnosis (meet diagnostic criteria for ADHD on the SCID-5 module for adult ADHD).
2. Planning to live in the area for at least the next 6 weeks;
3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form;
4. Able to communicate fluently in English (speaking, writing, and reading).

Exclusion Criteria:

Subjects who present and/or self-report with the following criteria at any point during study participation will not be eligible to participate in the study:

Alcohol/Drugs:

1. History or current diagnosis or treatment for alcohol or drug abuse (as reported during phone screen);
2. Positive breath alcohol concentration test (BrAC greater than or equal to 0.01) at intake;
3. A positive urine drug screen for cocaine, phencyclidine (PCP), amphetamines, methamphetamines, benzodiazepines, methadone, and/or barbiturates at Intake, Baseline, or Sessions 5, 10, 15 or 20.

Medication:

Current use or recent discontinuation (within the past 6 months at the time of Intake) of:

1. Gamma-Aminobutyric Acid (GABA)-ergic medications
2. Glutamatergic medications
3. Any medication for the treatment of ADHD
4. Benzodiazepines
5. Any medication that is known to lower the seizure threshold (e.g.,clozapine, bupropion, tramadol, carbapenems, stimulants)
6. Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician

   Current use or recent discontinuation (within the last 14 days at the time of Intake) of:
7. Anti-psychotic medications
8. Nicotine replacement therapy (NRT)

   Daily use of:
9. Opiate-containing medications for chronic pain

Medical/Neuropsychiatric:

1. Women who are pregnant, planning a pregnancy, and/or breast feeding.
2. History of seizures, epilepsy, or history of epilepsy in first-degree relative
3. History of stroke or transient ischemic attack (warning stroke)
4. History of traumatic brain injury or self-report of brain or spinal tumor
5. History of head injury with unconsciousness lasting more than 5 minutes
6. Previous brain surgery
7. Any additional neurological condition that would likely reduce the safety of study participation, including central nervous system (CNS) vasculitis, intracranial tumor, intracranial aneurysm, multiple sclerosis or arteriovenous malformations
8. History of tinnitus
9. History of diabetes mellitus
10. History of atherosclerotic vascular disease
11. A medically unstable cardiopulmonary or metabolic disorder
12. Increased risk for myocardial infarction or other major cardiopulmonary complications.
13. Any uncorrected visual impairment or abnormality
14. Self-reported history, current diagnosis of psychosis or symptoms consistent with a mood disorder based upon the Structured Clinical Interview for DSM-5 (SCID); including schizophrenia, mania, bipolar disorder, an eating disorder, obsessive compulsive disorder, an anxiety disorder, major depression (subjects with a history of major depression but in remission for past 6 months are eligible).

TMS-related:

1. Subjects with ferromagnetic material in or in close proximity to the head (with the exception of oral dental devices)
2. Implanted devices (including vagus nerve stimulator (VNS), deep brain stimulator (DBS), pacemakers, spinal cord stimulators, medication pumps, ventriculo peritoneal shunts, defibrillators, intracardiac lines)
3. Self-report of any skull fracture or opening
4. A disturbance in normal sleep patterns/sleep deprivation

General Exclusion:

1. Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, or affect clinical or cognitive outcomes, as determined by the Principal Investigator
2. Inability to complete study tasks and provide quality data, as determined by the Principal Investigator
3. Low or borderline intellectual functioning - determined by a score of less than 90 on the Shipley Institute of Living Scale (SILS) (administered at Intake Visit). The SILS correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated Intelligence Quotient (IQ) Test
4. Inability to provide informed consent

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Philadelphia

**Country:** United States

**Facility:** University of Pennsylvania

**State:** Pennsylvania

**Zip:** 19104

#### Overall Officials

**Official 1:**

**Affiliation:** University of Pennsylvania

**Name:** James Loughead, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-01-29

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 534775

- Type Abbrev: Prot_SAP

- Upload Date: 2019-09-09T16:00

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019958

- Term: Attention Deficit and Disruptive Behavior Disorders

- ID: D000065886

- Term: Neurodevelopmental Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000020820

- Term: Dyskinesias

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4594

- Name: Attention Deficit Disorder with Hyperactivity

- Relevance: HIGH

- As Found: Attention Deficit Disorder With Hyperactivity

- ID: M9999

- Name: Hyperkinesis

- Relevance: HIGH

- As Found: Hyperactivity

- ID: M21830

- Name: Attention Deficit and Disruptive Behavior Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30644

- Name: Neurodevelopmental 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: M22574

- Name: Dyskinesias

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006948

- Term: Hyperkinesis

- ID: D000001289

- Term: Attention Deficit Disorder with Hyperactivity

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Active TMS

**Deaths Num At Risk:** 18

**Description:** Participants will receive 20 sessions of active TMS targeting the left DLPFC.

Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).

**ID:** EG000

**Other Num Affected:** 4

**Other Num at Risk:** 18

**Serious Number At Risk:** 18

**Title:** Active TMS

**Group ID:** EG001

**Title:** Sham TMS

**Deaths Num At Risk:** 14

**Description:** Participants will receive 20 sessions of sham TMS over the left DLPFC.

Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).

**ID:** EG001

**Other Num Affected:** 1

**Other Num at Risk:** 14

**Serious Number At Risk:** 14

**Title:** Sham TMS

**Frequency Threshold:** 5

#### Other Events

**Term:** Sleep disturbance

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Participant experienced insomnia several times during the first week of treatment and revealed a history of insomnia prior to enrollment.

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** allergic reaction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Participant unknowingly consumed peanuts while at their personal gym and experienced an allergic reaction.

**Organ System:** Immune system disorders

**Source Vocabulary:** 

**Term:** Visual disturbance

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Participant reported seeing a white flash while completing computer tasks after receiving her 10th session of TMS.

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** Injury

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Participant diagnosed with tendinitis in left foot and needed to wear a boot.

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Depression symptoms

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Participant reported depression symptoms.

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Time Frame:** Baseline until end of treatment, an average of 4 weeks.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 14

**Group ID:** BG001

**Value:** 13

**Group ID:** BG002

**Value:** 27

**Units:** Participants

### Group

**ID:** BG000

**Title:** Active TMS

**Description:** Participants will receive 20 sessions of active TMS targeting the left DLPFC.

Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).

### Group

**ID:** BG001

**Title:** Sham TMS

**Description:** Participants will receive 20 sessions of sham TMS over the left DLPFC.

Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.9

**Value:** 32.9

#### Measurement

**Group ID:** BG001

**Spread:** 6.0

**Value:** 36.0

#### Measurement

**Group ID:** BG002

**Spread:** 13.0

**Value:** 34.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 9

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 18

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**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:** 2

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

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

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 19

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 11

**Category Title:** high school/some college

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 16

**Category Title:** college graduate

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** smokers

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 21

**Category Title:** non-smokers

**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:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Education
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Smoking Status
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** lleah@pennmedicine.upenn.edu
**Organization:** University of Pennsylvania
**Phone:** 2157467162
**Title:** Leah Bernardo
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.4
- **Upper Limit:** 
- **Value:** -4.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.6
- **Upper Limit:** 
- **Value:** -5.1
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 17.6
- **Upper Limit:** 
- **Value:** -16.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18.0
- **Upper Limit:** 
- **Value:** -4.8
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** ADHD symptoms will be assessed using the well-validated Conners Adult ADHD Rating Scale - Self-Report: Long Version (CAARS-S:L). The CAARS-S:L is a 66-item rating scale designed to assess ADHD symptoms in adults. The scale contains multiple subscales to assess Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) specified ADHD criteria as well as other facets of ADHD such as inattention/memory problems, hyperactivity/restlessness, impulsivity/emotionality, and problems with self-concept. Subscale results are converted to T-scores (range: 25-90), where 50 is the standardized population mean and every 10 points indicates one standard deviation from the mean. Higher values generally indicate more difficulties with ADHD symptoms. This measure will be administered at baseline at at the end of 4 weeks of treatment. The primary outcome will be the change from baseline to week 4.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline and week 4
**Title:** Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms)
**Type:** PRIMARY
**Unit of Measure:** t-score
##### Group
**Description:** Participants will receive 20 sessions of active TMS targeting the left DLPFC.

Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
**ID:** OG000
**Title:** Active TMS
##### Group
**Description:** Participants will receive 20 sessions of sham TMS over the left DLPFC.

Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
**ID:** OG001
**Title:** Sham TMS
#### Outcome Measure 2
**Description:** The Conners Continuous Performance Task (Conners CPT) will be administered and baseline and weekly during the treatment period to assess sustained attention. In this task, participants are shown a series of letters on a computer screen and are asked to press the spacebar in response to all letters except for the letter X. The primary outcome for the Conners CPT is the change in number of commission errors (e.g., false positives) from baseline to week 4.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline and week 4
**Title:** Change in Performance on Conners Continuous Performance Task (Sustained Attention)
**Type:** SECONDARY
**Unit of Measure:** Commission Errors
##### Group
**Description:** Participants will receive 20 sessions of active TMS targeting the left DLPFC.

Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
**ID:** OG000
**Title:** Active TMS
##### Group
**Description:** Participants will receive 20 sessions of sham TMS over the left DLPFC.

Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
**ID:** OG001
**Title:** Sham TMS
### Participant Flow Module
#### Group
**Description:** Participants will receive 20 sessions of active TMS targeting the left DLPFC.

Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
**ID:** FG000
**Title:** Active TMS
#### Group
**Description:** Participants will receive 20 sessions of sham TMS over the left DLPFC.

Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
**ID:** FG001
**Title:** Sham TMS
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Revealed exclusionary condition
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 18
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 14
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 13
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
**Has Results:** True