NCT06434766 Multicenter iTBS Neuromodulation for PTSD Treatment
| NCT ID | NCT06434766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Posttraumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-10-30 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2024-10-30 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Yuan Shen, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Shanghai Mental Health Center
Frequently Asked Questions
Who can join the NCT06434766 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Posttraumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06434766 currently recruiting?
Yes, NCT06434766 is actively recruiting participants. Contact the research team at hhq0301@zju.edu.cn for enrollment information.
Where is the NCT06434766 trial being conducted?
This trial is being conducted at Shanghai, China, Hangzhou, China, Hangzhou, China, Ningbo, China and 1 additional location.
Who is sponsoring the NCT06434766 clinical trial?
NCT06434766 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Yuan Shen, M.D., Ph.D. at Shanghai Mental Health Center. The trial plans to enroll 140 participants.