Informations générales (source: ClinicalTrials.gov)
Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD, a Randomized Double Blind Sham Controlled Trial (TraumaStim) (TraumaStim)
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mars 2024
octobre 2026
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital La Pitié-Salpêtrière | FERRERI Florian | 18/04/2025 07:55:27 | Contacter | ||
| AP-HP - Hôpital Saint Antoine | FERRERI Florian | 18/04/2025 07:55:27 | Contacter | ||
| AP-HP - Hôpital Tenon | FERRERI Florian | 12/04/2024 09:27:46 | Contacter | ||
Critères
Tous
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
- 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