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

Last updated: May 7, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

Repetitive Transcranial Magnetic Stimulation (rTMS)

Placebo

Clinical Study ID

NCT06111976
APHP200044
2021-A02532-39-B
  • Ages 18-65
  • All Genders

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 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

Study Design

Total Participants: 102
Treatment Group(s): 2
Primary Treatment: Repetitive Transcranial Magnetic Stimulation (rTMS)
Phase:
Study Start date:
March 07, 2024
Estimated Completion Date:
October 07, 2026

Study 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 optimal treatment alternatives for non-responders PTSD patients are unknown.

Functionally, the metabolic activity of the prefrontal-amygdala cortex circuit in PTSD is significantly altered. Repetitive Transcranial Magnetic Stimulation (rTMS) provides focused, non-invasive stimulation of cortical areas of the central nervous system and could correct cortical defective activation of the prefrontal cortex seen in PTSD Patient (FDA has already approved rTMS for depression and acoustic-verbal hallucinations treatment).

Pairing rTMS with cues relevant to the trauma may be a novel approach to treat PTSD patient.

The study will enroll 102 subjects with resistant PTSD. After screening and inclusion phase, the treatment phase with 12 sessions of rTMS and simultaneous reactivation of traumatic memory or sham rTMS and simultaneous reactivation of traumatic memory will be performed (3 to 4 weeks). Antidepressant treatment will be maintained. The follow up phase consist of 3 visits at M1, M3 and M6 to follow the evolution of the PTSD symptoms.

Connect with a study center

  • Saint Antoine Hospital, Psychiatry department, Assistance Publique- Hôpitaux de Paris

    Paris, 75012
    France

    Active - Recruiting

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