Precise Transcranial Magnetic Stimulation for PTSD

Study on the Effect and Mechanism of Individualized and Precise Location Transcranial Magnetic Stimulation Based on Magnetic Resonance Imaging on Post-traumatic Stress Disorder

This study is testing whether a specific type of brain stimulation can help people with PTSD feel better compared to a placebo treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xijing Hospital (other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT05544110 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) for patients with post-traumatic stress disorder (PTSD). Participants will be divided into two groups based on MRI-determined stimulation targets, with one group receiving active rTMS for 10 consecutive days and the other receiving sham stimulation. Symptom severity will be assessed using various scales and recordings at baseline, during treatment, and at follow-up. Additionally, blood samples will be collected to explore biological responses to the intervention across different patient subgroups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who meet the diagnostic criteria for PTSD and have a specific symptom severity score.

Not a fit: Patients with stable PTSD on existing medication or psychotherapy for over three weeks prior to the study may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from PTSD.

How similar studies have performed: Other studies have shown promise with transcranial magnetic stimulation for PTSD, indicating potential for success with this precise localization approach.

Eligibility criteria

Inclusion Criteria:

* The subject, regardless of gender, aged between 18 and 65 years, is admitted to the psychosomatic outpatient department of the First Affiliated Hospital of Air Force Medical University;
* The subject meets the diagnostic criteria of post-traumatic stress disorder in Diagnostic and Statistical Manual of Mental Disorders-5;
* The score of Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 \> 33；
* The subject can understand and is willing to strictly abide by the clinical trial protocol and signs the informed consent.

Exclusion Criteria:

* The subject has serious physical diseases or diseases that may affect the central nervous system (such as tumor, syphilis, etc.);
* Patients with PTSD who keep stable on their original medication/psychotherapy for more than 3 weeks before the start of the study or who have not taken the relevant therapeutic medication for more than 2 weeks before the start of the study will be included.Otherwise they will be excluded;
* The subject had previous brain diseases, head trauma, alcoholism, EEG abnormalities, MRI evidence of abnormal brain structure, or family history of epilepsy;
* The subject has contraindications to MRI scanning or transcranial magnetic stimulation treatment, such as metal or electronic instruments (intracranial metal foreign bodies, cochlear implants, cardiac pacemakers, stents and other metal foreign bodies) and space phobia;
* The subject has a history of contact with psychoactive substances or other mental diseases;
* Those at high risk of suicide, or those who have committed suicide or serious self injury and need emergency intervention;
* Pregnant, breastfeeding or planning pregnancy during the trial;
* In the judgment of the investigator, the subject has other conditions that are not suitable for the study.

Where this trial is running

Xi'an, Shaanxi

• XIJING Hospital — Xi'an, Shaanxi, China (RECRUITING)

Study contacts

• Principal investigator: Huaning Wang — Xijing Hospital
• Study coordinator: Yaochi Zhang

Conditions: PTSD, Transcranial magnetic stimulation