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

Post Traumatic Stress Disorder Clinical Trial

— TraumaStim  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111976
• Other study ID #: APHP200044
• Secondary ID: 2021-A02532-39-B
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2024
• Est. completion date: October 7, 2026

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Florian FERRERI, MD, Ph
• Phone: +33149282635
• Email: florian.ferreri[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: October 7, 2026
• Est. primary completion date: July 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Repetitive Transcranial Magnetic Stimulation (rTMS)
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
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.

Locations

Country	Name	City	State
France	Saint Antoine Hospital, Psychiatry department, Assistance Publique- Hôpitaux de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PTSD severity scores at M3 and M6 measured with CAPS-5	The different dimensions of PTSD (assess by CAPS-5): Severity, repetition, avoidance, neurovegetative activation at M3 and M6 post treatment	At inclusion (v1), Month 3 and Month 6 post treatment
Secondary	The severity of PTSD assessed by PCL-5 at each visit.	PTSD severity score measured with the PTSD Checklist (PCL-S self-questionnaire) at once a during TMS sessions, M1, M3 and M6 post treatment	at once a during TMS sessions, Month1, Month 3 and Month 6 post treatment.
Secondary	Dissociative symptoms severity scores (1)	Dissociative symptoms severity score measured with the Clinician Administered Dissociative States Scale (CADSS)	at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment
Secondary	Dissociative symptoms severity scores (2)	The Multidimensional Assessment of Interoceptive Awareness (MAIA)	at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment
Secondary	Dissociative symptoms severity scores (3)	The Dissociative Experiences Scale (DES)	at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment
Secondary	The severity scores of the dimensions of anxiety at V13 (end of treatment), M1, M3, M6 post treatment.	The severity scores of the dimensions of anxiety measured with HAM-A at V13 (end of treatment), M1, M3 and M6.	Up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment.
Secondary	Symptoms of depression at V13 (end of treatment), M1, M3, M6 post treatment.	The severity scores of the dimensions of depression measured with HAM-D at V13 (end of treatment), M1, M3 and M6.	at V13 (end of treatment), Month 1, Month 3, Month 6 post treatment.
Secondary	Evolution of social cognition at M3 post treatment.	Evolution of social cognition at M3 post treatment by a neuropsychologist	at Month 3 post treatment
Secondary	Quality of life	Quality of life evolution post treatment and M6 assessed by WHOQOL EuroQol Health Measure	post treatment and Month 6
Secondary	Quality of life	Quality of life evolution post treatment and M6 assessed by EQ-5D-5L	post treatment and Month 6
Secondary	Proportion of adverse events during the active treatment phase and during the follow-up	Number and description of adverse events during the active treatment phase and during the follow-up	through study completion, up to 6 months