Actively Recruiting
Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-05-08
102
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 65 years.
- Diagnosed with PTSD according to DSM-5 criteria.
- Persistent PTSD symptoms (PCL-5 > 40) after at least 6 weeks of treatment with paroxetine or sertraline.
- Have health insurance (excluding AME).
- Signed written informed consent.
You will not qualify if you...
- History of epilepsy or seizures.
- Presence of cochlear implants.
- Having a cardiac pacemaker, intracardiac lines, or metal in the body.
- Previous treatment with rTMS, electroconvulsive therapy (ECT), or transcranial direct current stimulation (tDCS).
- Currently undergoing PTSD-oriented cognitive-behavioral therapy.
- History of lifetime psychotic disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder.
- Brain injury documented by medical report, including atrophy, dementia, stroke, transient ischemic attack, or head trauma.
- Current substance dependence, including alcohol (excluding tobacco).
- Acute suicidal thoughts.
- Inadequate mastery of French or inability to consent.
- Pregnancy, breastfeeding, or lack of birth control.
- Under legal protection measures or deprived of freedom.
- Participation in any other interventional study or within an exclusion period for other interventional studies.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Saint Antoine Hospital, Psychiatry department, Assistance Publique- Hôpitaux de Paris
Paris, France, 75012
Actively Recruiting
Research Team
F
Florian FERRERI, MD, Ph
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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