Multicenter iTBS Neuromodulation for PTSD Treatment

NCT06434766 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Not applicable

Started

2024-10-30

Last updated

2026-08-03

Condition(s) studied

Posttraumatic Stress Disorder

Investigational drug(s) / intervention(s)

sham stimulationintermittent theta-burst stimulation (iTBS)

sham stimulation: sham theta-burst transcranial magnetic stimulation

intermittent theta-burst stimulation (iTBS): intermittent theta-burst transcranial magnetic stimulation

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Change in PTSD Symptom Severity — Baseline and 4 weeks after finishing treatment
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.

Trial sites (5)

Facility	City	Region	Status
Shanghai Mental Health Center	Shanghai	Shanghai Municipality	Recruiting
First Affiliated Hospital of Anhui Medical University	Hangzhou	Zhejiang	Recruiting
Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting
The Affiliated Kangning Hospital of Ningbo University	Ningbo	Zhejiang	Recruiting
Tongji Hospital of Tongji University	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06434766 on ClinicalTrials.gov ↗ ← All trials in China