Multicenter iTBS Neuromodulation for PTSD Treatment

NCT06434766 | Recruiting DMC

• 1 other identifier: yan2024-0108
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

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.

Conditions

Posttraumatic Stress Disorder

Keywords

iTBS; PTSD

Outcome Measures

Primary Outcomes (1)

• Change in PTSD Symptom Severity

  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.

  Baseline and 4 weeks after finishing treatment

Secondary Outcomes (6)

• Change in PTSD Symptom Severity

  Baseline, 10 times treatment, 20 times treatment, 2 weeks after finishing treatment and 8 weeks after finishing treatment

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

  Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment

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

  Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment

• Change in The Personal Social Performance (PSP) scale

  Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment

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

  Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment

Study Arms (2)

Sham stimulation

SHAM COMPARATOR

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.

Device: sham stimulation

Active stimulation

ACTIVE COMPARATOR

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).

Device: intermittent theta-burst stimulation (iTBS)

Interventions

sham stimulation DEVICE

sham theta-burst transcranial magnetic stimulation

Sham stimulation

intermittent theta-burst stimulation (iTBS) DEVICE

intermittent theta-burst transcranial magnetic stimulation

Active stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Tongji Hospital: collaborator
• Shanghai Mental Health Center: collaborator
• The Affiliated Kangning Hospital of Ningbo University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator

Study Sites (5)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

RECRUITING

First Affiliated Hospital of Anhui Medical University

Hangzhou, Zhejiang, China

RECRUITING

Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

The Affiliated Kangning Hospital of Ningbo University

Ningbo, Zhejiang, China

RECRUITING

Tongji Hospital of Tongji University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Yuan Shen, M.D., Ph.D.

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

• Chang Yu, M.D.

  The Affiliated Kangning Hospital of Ningbo University

  PRINCIPAL INVESTIGATOR

• Kai Wang, M.D., Ph.D.

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Xiaoming Li, M.D., Ph.D.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiqian Huang, Ph.D.

CONTACT

+8618757143725; hhq0301@zju.edu.cn

Shanshan Li, Bachelor

CONTACT

1252037349@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators and outcomes assessors are all blind to the group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sham stimulation is used as a parallel control group for iTBS group.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 30, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)