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NCT Number: NCT06111976

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Month 1 after 12 sessions of rTMS

    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)

Secondary outcomes

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

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

    The different dimensions of PTSD (assess by CAPS-5): Severity, repetition, avoidance, neurovegetative activation at M3 and M6 post treatment

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

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

    PTSD severity score measured with the PTSD Checklist (PCL-S self-questionnaire) at once a during TMS sessions, M1, M3 and M6 post treatment

  3. Dissociative symptoms severity scores (1)

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

    Dissociative symptoms severity score measured with the Clinician Administered Dissociative States Scale (CADSS)

  4. Dissociative symptoms severity scores (2)

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

    The Multidimensional Assessment of Interoceptive Awareness (MAIA)

  5. Dissociative symptoms severity scores (3)

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

    The Dissociative Experiences Scale (DES)

  6. The severity scores of the dimensions of anxiety at V13 (end of treatment), M1, M3, M6 post treatment.

    Time frame: Up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment.

    The severity scores of the dimensions of anxiety measured with HAM-A at V13 (end of treatment), M1, M3 and M6.

  7. Symptoms of depression at V13 (end of treatment), M1, M3, M6 post treatment.

    Time frame: at V13 (end of treatment), Month 1, Month 3, Month 6 post treatment.

    The severity scores of the dimensions of depression measured with HAM-D at V13 (end of treatment), M1, M3 and M6.

  8. Evolution of social cognition at M3 post treatment.

    Time frame: at Month 3 post treatment

    Evolution of social cognition at M3 post treatment by a neuropsychologist

  9. Quality of life

    Time frame: post treatment and Month 6

    Quality of life evolution post treatment and M6 assessed by WHOQOL EuroQol Health Measure

  10. Quality of life

    Time frame: post treatment and Month 6

    Quality of life evolution post treatment and M6 assessed by EQ-5D-5L

  11. Proportion of adverse events during the active treatment phase and during the follow-up

    Time frame: through study completion, up to 6 months

    Number and description of adverse events during the active treatment phase and during the follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Florian FERRERI, MD, Ph

CONTACT

[email protected]

+33149282635

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: TraumaStim

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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