## Protocol Section
### Identification Module
**NCT ID:** NCT06434766

**Acronym:** TMCP

**Brief Title:** Multicenter iTBS Neuromodulation for PTSD Treatment

**Official Title:** A Multicenter Clinical Study on Transcranial Magnetic Stimulation of the Primary Motor Cortex for PTSD Treatment

#### Organization Study ID Info
**ID:** yan2024-0108
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
### Status Module
#### Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

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

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Shanghai Mental Health Center

**Class:** UNKNOWN

**Name:** The Affiliated Kangning Hospital of Ningbo University

**Class:** OTHER

**Name:** The First Affiliated Hospital of Anhui Medical University

#### Lead Sponsor

**Class:** OTHER

**Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex (M1) as adjunct treatment for PTSD patients. The primary outcome measure includes changes in PTSD symptom severity, with secondary outcome measures focusing on negative moods improvements, quality of life and social/occupation functioning and functional connectivity of the brain.

**Detailed Description:** The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex as adjunct treatment for PTSD patients.

Compared to traditional repetitive transcranial magnetic stimulation (rTMS), iTBS strategy usually delivers large amounts of pulses in a shorter time period, and its equal efficiency has been demonstrated in several psychiatric disorders such as major depressive disorder (MDD). Through this adequately randomized and sham-controlled study of iTBS for PTSD, this work will provide an alternative and potentially more potent stimulation target for clinical PTSD treatment. This study will also provide a comprehensive assessment of this treatment strategy towards improvements in symptoms, quality of life and brain functioning in PTSD.

The ultimate goal of this study is to develop a non-invasive brain stimulation approach targeting a novel site for alleviating symptoms and improving life quality for PTSD patients.

### Conditions Module

**Conditions:**

- Posttraumatic Stress Disorder

**Keywords:**

- iTBS

- PTSD

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Sham stimulation is used as a parallel control group for iTBS group.

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** Participants, investigators and outcomes assessors are all blind to the group assignments.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 140

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** A sham coil with exactly the same appearance of active coil is used to compare with active coil. Stimulation dose and frequency is the same as active stimulation.

**Intervention Names:**

- Device: sham stimulation

**Label:** Sham stimulation

**Type:** SHAM_COMPARATOR

#### Arm Group 2

**Description:** An active coil is used to deliver iTBS. The stimulation dose is 20 sessions (1800 pulses per session; 2 sessions a day, at least 1 hour apart) over the course of 2 weeks (10 days to 14 days, allow at most three breaks and only once of the longest interval of 2 days).

**Intervention Names:**

- Device: intermittent theta-burst stimulation (iTBS)

**Label:** Active stimulation

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sham stimulation

**Description:** sham theta-burst transcranial magnetic stimulation

**Name:** sham stimulation

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Active stimulation

**Description:** intermittent theta-burst transcranial magnetic stimulation

**Name:** intermittent theta-burst stimulation (iTBS)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).

The CAPS-5 is a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The structure corresponds to the DSM-5 criteria, with B, C, D and E symptoms rated for both frequency and intensity which are summed to provide severity ratings. Items rated '0' means 'absent' and item rated '4' means 'extreme/incapacitating'. Higher scores indicate more severe PTSD symptoms.

**Measure:** Change in PTSD Symptom Severity

**Time Frame:** Baseline and 4 weeks after finishing treatment

#### Secondary Outcomes

**Description:** Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).

**Measure:** Change in PTSD Symptom Severity

**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2 weeks after finishing treatment and 8 weeks after finishing treatment

**Description:** The PCL-5 is a 20-item self-report checklist of PTSD symptoms based closely on the DSM-5 criteria. Respondents rate each item from 0 ("not at all") to 4 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month (or past week if using the PCL-5 weekly). A total symptom severity score (range: 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating more severe PTSD symptoms.

**Measure:** Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score

**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment

**Description:** The IDS-SR is a 30-item questionnaire measuring depressive symptoms. Each item has four statements that reflect various degrees of symptom severity, scored on a four-point scale from 0 to 3. The 16-item Quick Inventory of Depressive Symptomatology (QIDS) is a new measure of depressive symptom severity derived from the 30-item IDS-SR and has highly acceptable psychometric properties.

**Measure:** Change in The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) Score

**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment

**Description:** The Personal and Social Performance Scale (PSP) is a 100-point single-item rating scale that assesses four important domains of patients with mental disorders. The four main areas include (a) socially useful activities, including work and study; (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors.

**Measure:** Change in The Personal Social Performance (PSP) scale

**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment

**Description:** Q-LES-Q-SF is a patient-reported 16-item instrument that measures the degree of enjoyment and satisfaction in daily life over the past week. Individual items are rated on a scale from 1-5 ('very poor', 'poor', 'fair', 'good', or 'very good'). The Q-LES-Q-SF total score is the sum of the first 14 item scores (i.e. excluding medication satisfaction and overall life satisfaction and contentment) with a higher score indicating greater satisfaction (range = 14-70).

**Measure:** change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)

**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment

**Description:** Structural, resting-state and task-based fMRI will be performed if the participant agree. During task-fMRI, the participant will listen to a script around one minute recorded during his/her first interview, describing the traumatic experience in details. The participant will be instructed to recall the traumatic experience vividly during the task-fMRI. Brain activity patterns and connectivity network will be presented and analyzed.

**Measure:** Change in neural activity pattern and functional connectivity of the brain based on fMRI

**Time Frame:** Baseline, 20 times treatment, 4 weeks after finishing treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged between 18 to 65 years old
* Right handedness
* Have a diagnosis of PTSD meeting DSM-5 criteria
* CAPS-5 score\>35
* Under stable medication for at least four weeks
* Capable of independently reading and understanding study materials and providing informed consent.

Exclusion Criteria:

* Current (or past if appropriate) significant neurological or medical disorder, or lifetime history of 1) seizure disorder; 2) primary or secondary CNS tumors; 3) stroke; or 4) cerebral aneurysm.
* Primary psychotic disorder, bipolar I disorder, major depressive disorder, or personality disorders
* Lifetime history of attempted suicide or HAMD-17 suicide item (item 3) ≥ 3 points
* Implanted device (deep brain stimulation) or metal in the brain; a pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos if choose to do fMRI
* Previous experience of rTMS
* Pregnancy/lactation, or planning to become pregnant during the study
* Current under psychological or other physical treatments

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hhq0301@zju.edu.cn

**Name:** Huiqian Huang, Ph.D.

**Phone:** (+86)18757143725

**Role:** CONTACT

**Contact 2:**

**Email:** 1252037349@qq.com

**Name:** Shanshan Li, Bachelor

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Shanghai Mental Health Center

**Name:** Yuan Shen, M.D., Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** The Affiliated Kangning Hospital of Ningbo University

**Name:** Chang Yu, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** The First Affiliated Hospital of Anhui Medical University

**Name:** Kai Wang, M.D., Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Second Affiliated Hospital, School of Medicine, Zhejiang University

**Name:** Xiaoming Li, M.D., Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000040921

- Term: Stress Disorders, Traumatic

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: LOW

- As Found: Unknown

- ID: M16103

- Name: Stress Disorders, Post-Traumatic

- Relevance: HIGH

- As Found: Posttraumatic Stress Disorder

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related 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

### Condition Browse Module - Meshes

- ID: D000013313

- Term: Stress Disorders, Post-Traumatic

### Misc Info Module

- Version Holder: 2024-05-31
