Using brain stimulation and memory reactivation to treat 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)

This study is testing if a new treatment using brain stimulation and memory cues can help people with tough-to-treat PTSD feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT06111976 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of repetitive transcranial magnetic stimulation (rTMS) combined with traumatic memory reactivation in patients with resistant post-traumatic stress disorder (PTSD). It is a multicenter, randomized, double-blind, sham-controlled study that aims to enroll 102 subjects who have not responded to standard antidepressant treatments. Participants will undergo 12 sessions of rTMS alongside memory reactivation cues over a treatment phase of 3 to 4 weeks, followed by follow-up visits to assess changes in PTSD symptoms. The study seeks to explore a novel approach to address the significant public health concern of PTSD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of PTSD who have persistent symptoms despite at least 6 weeks of antidepressant treatment.

Not a fit: Patients with contraindications for rTMS, such as a history of epilepsy or ongoing cognitive-behavioral therapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with resistant PTSD who have not benefited from conventional therapies.

How similar studies have performed: While rTMS has been approved for other conditions, this specific combination approach for PTSD is novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

Paris

• Saint Antoine Hospital, Psychiatry department, Assistance Publique- Hôpitaux de Paris — Paris, France (Recruiting)

Study contacts

• Principal investigator: Florian FERRERI, MD, ph — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Florian FERRERI, MD, Ph

Conditions Post Traumatic Stress Disorder; Stress Disorders; Traumatic Stress Disorders; Post-Traumatic Trauma and Stressor Related Disorders; Mental Disorders