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

NCT06111976 | Recruiting

• 2 other identifiers: APHP2000442021-A02532-39-B
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Traumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PTSD severity score measured at M1 after 12 sessions of rTMS or sham rTMS and simultaneous reactivation of traumatic memory

  CAPS-5 total severity score at M1 post treatment will be compared between groups (cerebral modulation by rTMS with simultaneous reactivation of traumatic memory VS sham rTMS with simultaneous reactivation of traumatic memory)

  Month 1 after 12 sessions of rTMS

Secondary Outcomes (11)

• PTSD severity scores at M3 and M6 measured with CAPS-5

  At inclusion (v1), Month 3 and Month 6 post treatment

• The severity of PTSD assessed by PCL-5 at each visit.

  at once a during TMS sessions, Month1, Month 3 and Month 6 post treatment.

• Dissociative symptoms severity scores (1)

  at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment

• Dissociative symptoms severity scores (2)

  at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment

• Dissociative symptoms severity scores (3)

  at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment

Study Arms (2)

rTMS with simultaneous reactivation of traumatic memory in resistant PTSD

EXPERIMENTAL

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

Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

sham rTMS and simultaneous reactivation of traumatic memory in resistant PTSD

PLACEBO COMPARATOR

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

Procedure: Placebo

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) PROCEDURE

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.

rTMS with simultaneous reactivation of traumatic memory in resistant PTSD

Placebo PROCEDURE

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.

sham rTMS and simultaneous reactivation of traumatic memory in resistant PTSD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Mental Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Florian FERRERI, MD, ph

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian FERRERI, MD, Ph

CONTACT

+33149282635; florian.ferreri@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 1, 2023
• Study Start: March 7, 2024
• Primary Completion (Estimated): July 7, 2026
• Study Completion (Estimated): October 7, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)