Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD, a Randomized Double Blind Sham Controlled Trial (TraumaStim)
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Patients aged between 18 and 65 years.
• Presenting a PTSD according to DSM-5 criteria
• Patient with persistent symptoms (PCL-5\>40) after a 6 weeks treatment with labelled antidepressant for PTSD (paroxetine or sertraline)
• Patient with health insurance (AME excepted)
• Signed written inform consent
Locations
Other Locations
France
Saint Antoine Hospital, Psychiatry department, Assistance Publique- Hôpitaux de Paris
RECRUITING
Paris
Contact Information
Primary
Florian FERRERI, MD, Ph
florian.ferreri@aphp.fr
+33149282635
Time Frame
Start Date: 2024-03-07
Estimated Completion Date: 2026-10-07
Participants
Target number of participants: 102
Treatments
Experimental: rTMS with simultaneous reactivation of traumatic memory in resistant PTSD
rTMS with simultaneous reactivation of traumatic memory in resistant PTSD during 12 sessions (3 to 4 weeks)
Placebo_comparator: sham rTMS and simultaneous reactivation of traumatic memory in resistant PTSD
sham rTMS and simultaneous reactivation of traumatic memory in resistant PTSD during 12 sessions (3 to 4 weeks)
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris