RecruitingNot ApplicableNCT06111976

Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD

Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD, a Randomized Double Blind Sham Controlled Trial (TraumaStim)

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

102 participants

Start Date

Mar 7, 2024

Study Type

INTERVENTIONAL

Conditions

Post Traumatic Stress Disorder

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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 Criteria14

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

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Interventions

PROCEDURERepetitive 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.

PROCEDUREPlacebo

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.