RecruitingNot ApplicableNCT06111976

Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD

Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD, a Randomized Double Blind Sham Controlled Trial (TraumaStim)

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

102 participants

Start Date

Mar 7, 2024

Study Type

INTERVENTIONAL

Conditions

Post Traumatic Stress Disorder

Summary

A French multicenter randomized and double blinded shamed controlled study recruiting patients who present resistant PTSD. The aim of this trial is to assess the efficacy of cerebral modulation by rTMS with simultaneous reactivation of traumatic memory on the PTSD symptoms at M1.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining repetitive transcranial magnetic stimulation (rTMS — a non-invasive brain stimulation technique) with memory reactivation therapy reduces PTSD symptoms in patients who have not responded to standard antidepressant medications. **You may be eligible if...** - You are between 18 and 65 years old with a PTSD diagnosis (per standard criteria) - Your PTSD symptoms remain significant (PCL-5 score above 40) after at least 6 weeks of antidepressant treatment (paroxetine or sertraline) - You have health insurance and have signed informed consent **You may NOT be eligible if...** - You have epilepsy or a history of seizures - You have a cochlear implant, pacemaker, or metal in your body - You have previously had rTMS, ECT, or transcranial direct current stimulation - You have a lifetime diagnosis of psychosis, bipolar disorder, or borderline/antisocial personality disorder - You have a brain injury, dementia, or stroke history - You have current substance dependence or acute suicidal ideation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURERepetitive Transcranial Magnetic Stimulation (rTMS)

rTMS with simultaneous reactivation of traumatic memory will be performed 3 to 4 times a week for 3 to 4 weeks through 12 sessions. A traumatic script will be prepared by the patient at the inclusion visit, which will be used to reactivate the traumatic memory after every rTMS or sham rTMS sessions.

PROCEDUREPlacebo

sham rTMS with simultaneous reactivation of traumatic memory will be performed 3 to 4 times a week for 3 to 4 weeks through 12 sessions. A traumatic script will be prepared by the patient at the inclusion visit, which will be used to reactivate the traumatic memory after every rTMS or sham rTMS sessions.

Locations(1)

Saint Antoine Hospital, Psychiatry department, Assistance Publique- Hôpitaux de Paris

Paris, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06111976

Related Trials

Improving Mental Health in Forcibly Displaced Populations

NCT066354861 location

Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant

NCT059485409 locations