Using brain stimulation to treat PTSD
A Multicenter Clinical Study on Transcranial Magnetic Stimulation of the Primary Motor Cortex for PTSD Treatment
This study is testing a new brain stimulation technique to see if it can help people with PTSD feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 5 sites (Shanghai, Shanghai Municipality and 4 other locations) |
| Trial ID | NCT06434766 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS) on patients with posttraumatic stress disorder (PTSD). It targets the primary motor cortex and aims to improve PTSD symptoms, negative moods, quality of life, and brain functioning. The study employs a randomized and sham-controlled design to compare the effects of iTBS with a placebo treatment. By focusing on a novel stimulation approach, it seeks to provide a more effective non-invasive treatment option for PTSD patients.
Who should consider this trial
Good fit: Ideal candidates are right-handed adults aged 18 to 65 with a confirmed diagnosis of PTSD and a CAPS-5 score greater than 35.
Not a fit: Patients with significant neurological disorders, primary psychotic disorders, or a history of severe suicidal behavior may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate PTSD symptoms and enhance the quality of life for affected individuals.
How similar studies have performed: Previous studies have shown that similar brain stimulation techniques, like rTMS, have been effective in treating various psychiatric disorders, suggesting potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality and 4 other locations
- 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)
Study contacts
- Principal investigator: Yuan Shen, M.D., Ph.D. — Shanghai Mental Health Center
- Study coordinator: Huiqian Huang, Ph.D.
- Email: hhq0301@zju.edu.cn
- Phone: +8618757143725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.