## Protocol Section
### Identification Module
**NCT ID:** NCT06429748

**Acronym:** SET

**Brief Title:** Symptom Evaluation Following Repetitive Transcranial Magnetic Stimulation

**Official Title:** A Prospective Study to Evaluate Symptoms Following Repetitive Transcranial Magnetic Stimulation (rTMS)

#### Organization Study ID Info
**ID:** 44-50019-000
#### Organization
**Class:** OTHER
**Full Name:** Neuronetics
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Neuronetics

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A prospective study to evaluate symptoms following repetitive transcranial Magnetic stimulation.

**Detailed Description:** Open-label, multicenter, prospective pilot study conducted in an adult population receiving rTMS treatment.

### Conditions Module

**Conditions:**

- Neurologic Symptoms

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Single Group

**Intervention Names:**

- Device: rTMS

**Label:** Open Label

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Open Label

**Description:** repetitive Transcranial Magnetic Stimultion

**Name:** rTMS

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** Treatment related Adverse Events

**Measure:** Safety Outcome

**Time Frame:** 16 weeks

#### Primary Outcomes

**Description:** Assess changes in multiple symptoms scores based on patient reported questionnaires from baseline to end of acute.

**Measure:** Changes in multiple symptoms after rTMS treatment.

**Time Frame:** 4 weeks

#### Secondary Outcomes

**Description:** Assess changes in multiple symptoms scores based on patient reported questionnaires from baseline to final follow-up visit.

**Measure:** Durability of changes in symptoms

**Time Frame:** 16 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Adults, 22 to 70 years of age
2. Voluntarily provides written informed consent and agree to comply with study procedures, including attending all study visits and completing all study assessments.
3. Score \> or = 8 on ISI scale
4. If subject is on any psychiatric or sleep medication, dose must be stable for two weeks prior to enrollment and remain stable throughout the trial.
5. If female, not breastfeeding, no known or suspected pregnancy, a status of nonchildbearing potential or use of an acceptable form of birth control.
6. Subject on stable dose regime for other concurrent medications like hormonal therapy for menopause transition etc.

Exclusion Criteria:

1. Subject meets any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
2. History of head trauma associated with loss of consciousness or diagnosed as concussion.
3. History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)
4. Has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc.
5. Has an implanted stimulator device (including device leads) in or near the head. (e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.)
6. Has medication infusion device.
7. Subjects with any prior TMS or MRI complications, or any other issues/circumstance which, in the opinion of the investigator, might interfere with safety, study participation, or which might confound data interpretation.
8. PHQ-9 total score \> or = 10 or QIDS total score \> or = 11.
9. Drug abuse or dependence of the illicit substance. (Abuse or Dependence, as defined by DSM-V-TR)
10. Current diagnosis or known history of neurologic disease (e.g., epilepsy, convulsion, seizure)
11. Other known disorder (e.g., narcolepsy, a breathing-related sleep disorder like Obstructive Sleep Apnea, a circadian rhythm sleep-wake disorder, a parasomnia) as defined by DSM-V-TR.
12. Has a clinically significant abnormality on the screening examination.
13. Participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.

**Maximum Age:** 70 Years

**Minimum Age:** 22 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** neha.goyal@neurostar.com

**Name:** Neha Goyal

**Phone:** 7635281599

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Charlotte

**Contacts:**

***Contact 1:***

- **Email:** robyn@charlotteskinandlaser.com

- **Name:** Robyn Allen, RN

- **Phone:** 704-333-9113

- **Role:** CONTACT

***Contact 2:***

- **Name:** Elizabeth Rostan, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Charlotte Skin and Laser

**State:** North Carolina

**Status:** RECRUITING

**Zip:** 28207

#### Overall Officials

**Official 1:**

**Affiliation:** Neuronetics

**Name:** Steve Erickson

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: HIGH

- As Found: Neurologic Symptoms

### Condition Browse Module - Meshes

- ID: D000009461

- Term: Neurologic Manifestations

### Misc Info Module

- Version Holder: 2024-05-31
