Repetitive Transcranial Magnetic Stimulation (rTMS)Placebo
Repetitive 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.
Placebo: 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria :
* Contraindication for rTMS:
* History of epilepsy or seizure
* Cochlear implants
* Cardiac pacemaker or intracardiac lines, or metal in the body
* Patient has already had a rTMS session and/or Electroconvulsive therapy (ECT) and/or Transcranial direct current stimulation (tDCS)
* Ongoing PTSD-oriented cognitive-behavioral therapy
* Lifetime psychotic or bipolar disorder or antisocial personality or borderline personality
* Brain injury defined by medical report (including cortical and subcortical atrophy, dementia, stroke, transient ischemic attack and head trauma)
* Current substance dependence (including alcohol, excluding tobacco);
* Acute suicidal ideation
* No adequate mastering of the French language or no ability to consent
* Pregnancy (confirmed by a urine test beta-HCG) or breast feeding or absence of birth control
* Patient under legal protection measure and or deprived of freedom
* Participation in any other interventional study or in the exclusion period any other interventional study
Primary outcome measure(s)
PTSD severity score measured at M1 after 12 sessions of rTMS or sham rTMS and simultaneous reactivation of traumatic memory — Month 1 after 12 sessions of rTMS CAPS-5 total severity score at M1 post treatment will be compared between groups (cerebral modulation by rTMS with simultaneous reactivation of traumatic memory VS sham rTMS with simultaneous reactivation of traumatic memory)
Trial sites (1)
Facility
City
Region
Status
Saint Antoine Hospital, Psychiatry department, Assistance Publique- Hôpitaux de Paris
Paris
France
Recruiting
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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