RecruitingNot ApplicableNCT06434766

Multicenter iTBS Neuromodulation for PTSD Treatment

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

140 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of non-invasive brain stimulation called iTBS (intermittent theta burst stimulation) — which uses brief magnetic pulses directed at specific brain areas — as a treatment for post-traumatic stress disorder (PTSD) across multiple medical centers. **You may be eligible if...** - You are between 18 and 65 years old - You are right-handed - You have a confirmed diagnosis of PTSD meeting DSM-5 criteria, with a CAPS-5 score above 35 (indicating significant symptoms) - You have been on a stable medication regimen for at least 4 weeks - You can independently read, understand, and consent to participation **You may NOT be eligible if...** - You have a significant neurological condition such as a seizure disorder, brain tumor, stroke, or cerebral aneurysm - You have a primary psychotic disorder, bipolar I disorder, major depression, or personality disorder - You have a history of suicide attempt or are currently at high risk of suicide - You have a deep brain stimulator, pacemaker, or metal implants in your head - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEsham stimulation

sham theta-burst transcranial magnetic stimulation

DEVICEintermittent theta-burst stimulation (iTBS)

intermittent theta-burst transcranial magnetic stimulation


Locations(5)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

First Affiliated Hospital of Anhui Medical University

Hangzhou, Zhejiang, China

Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Affiliated Kangning Hospital of Ningbo University

Ningbo, Zhejiang, China

Tongji Hospital of Tongji University

Shanghai, China

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NCT06434766


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