Post Traumatic Stress DisorderTraumaStimNCT06111976
Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Post Traumatic Stress Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2024to 7 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Saint Antoine Hospital, Psychiatry department, Assistance Publique- Hôpitaux de Paris
Paris, 75012
Florian FERRERI, MD, PhD, +33149282635, florian.ferreri@aphp.fr
Alexis BOURLA, MD, +33149282635, alexis.bourla@aphp.fr
About this study
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)
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.
Read the detailed 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Placebo
- Keywords
- Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders, Mental Disorders
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Procedure or surgery
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.
PlaceboProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Month 1 after 12 sessions of rTMS
Secondary outcomes (11)
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
Measured: At inclusion (v1), Month 3 and Month 6 post treatment
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
Measured: at once a during TMS sessions, Month1, Month 3 and Month 6 post treatment.
Dissociative symptoms severity scores (1)
Dissociative symptoms severity score measured with the Clinician Administered Dissociative States Scale (CADSS)
Measured: at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment
Dissociative symptoms severity scores (2)
The Multidimensional Assessment of Interoceptive Awareness (MAIA)
Measured: at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment
Dissociative symptoms severity scores (3)
The Dissociative Experiences Scale (DES)
Measured: at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment
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.
Measured: Up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment.
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.
Measured: at V13 (end of treatment), Month 1, Month 3, Month 6 post treatment.
Evolution of social cognition at M3 post treatment.
Evolution of social cognition at M3 post treatment by a neuropsychologist
Measured: at Month 3 post treatment
Quality of life
Quality of life evolution post treatment and M6 assessed by WHOQOL EuroQol Health Measure
Measured: post treatment and Month 6
Quality of life
Quality of life evolution post treatment and M6 assessed by EQ-5D-5L
Measured: post treatment and Month 6
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
Measured: through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start7 Mar 2024
- Primary completion7 Jul 2026 (estimated)
- Study completion7 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian FERRERI, MD, ph, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111976
- Sponsor's protocol ID
- APHP200044
- Other IDs
- 2021-A02532-39-B
- Acronym
- TraumaStim
- Status last verified
- May 2024
- First submitted
- 12 Oct 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06111976
- Acronym / sponsor ID
- TraumaStim / APHP200044
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders, Mental Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 7 Jul 2026 (estimated)
- Study completion
- 7 Oct 2026 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS with simultaneous reactivation of traumatic memory in resistant PTSD | Experimental | Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)rTMS with simultaneous reactivation of traumatic memory in resistant PTSD during 12 sessions (3 to 4 weeks) |
| sham rTMS and simultaneous reactivation of traumatic memory in resistant PTSD | Placebo comparator | Procedure: Placebosham rTMS and simultaneous reactivation of traumatic memory in resistant PTSD during 12 sessions (3 to 4 weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- Contraindication for rTMS:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | rTMS with simultaneous reactivation of traumatic memory in resistant PTSD |
| Placebosham 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. | Procedure or surgery | sham rTMS and simultaneous reactivation of traumatic memory in resistant PTSD |
Primary outcome
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)
11 secondary outcomes
PTSD severity scores at M3 and M6 measured with CAPS-5
Time frame: At inclusion (v1), Month 3 and Month 6 post treatment
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.
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 scores (2)
Time frame: at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment
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 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.
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.
Evolution of social cognition at M3 post treatment.
Time frame: at Month 3 post treatment
Quality of life
Time frame: post treatment and Month 6
Quality of life
Time frame: post treatment and Month 6
Proportion of adverse events during the active treatment phase and during the follow-up
Time frame: through study completion, up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian FERRERI, MD, ph principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Post Traumatic Stress Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian FERRERI, MD, Ph (+33149282635, florian.ferreri@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.