Multicenter iTBS Neuromodulation for PTSD Treatment
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 mo
| Condition(s) | Posttraumatic Stress Disorder |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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, o |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Locations | Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China; Hangzhou, Zhejiang, China; Ningbo, Zhejiang, China; Shanghai, China |
| Start date | 2024-10-30 |
| NCT ID | NCT06434766 |
| Official listing | https://clinicaltrials.gov/study/NCT06434766 |