Status:
RECRUITING
Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 rTM...
Detailed Description
Detailed Description : PTSD is considered as one of the top 10 public health concerns. Most patients with PTSD receive pharmacologic treatment and traumatic reactivation therapy. However, to date, the...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 7 2026
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT06111976
Start Date
March 7 2024
End Date
October 7 2026
Last Update
May 8 2024
Active Locations (1)
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1
Saint Antoine Hospital, Psychiatry department, Assistance Publique- Hôpitaux de Paris
Paris, France, 75012