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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Post Traumatic Stress Disorder

Treatments: Procedure: Placebo; Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06111976

2021-A02532-39-B (Other Identifier)

APHP200044

Details and patient eligibility

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.

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 2 patient groups, including a placebo group

rTMS with simultaneous reactivation of traumatic memory in resistant PTSD

Experimental group

Description:

rTMS with simultaneous reactivation of traumatic memory in resistant PTSD during 12 sessions (3 to 4 weeks)

Treatment:

Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

sham rTMS and simultaneous reactivation of traumatic memory in resistant PTSD

Placebo Comparator group

Description:

sham rTMS and simultaneous reactivation of traumatic memory in resistant PTSD during 12 sessions (3 to 4 weeks)

Treatment:

Procedure: Placebo