Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD
NCT ID: NCT06111976
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
102 participants
INTERVENTIONAL
2024-03-07
2026-10-07
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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rTMS with simultaneous reactivation of traumatic memory in resistant PTSD
rTMS with simultaneous reactivation of traumatic memory in resistant PTSD during 12 sessions (3 to 4 weeks)
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.
sham rTMS and simultaneous reactivation of traumatic memory in resistant PTSD
sham rTMS and simultaneous reactivation of traumatic memory in resistant PTSD during 12 sessions (3 to 4 weeks)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Florian FERRERI, MD, ph
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Saint Antoine Hospital, Psychiatry department, Assistance Publique- Hôpitaux de Paris
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A02532-39-B
Identifier Type: OTHER
Identifier Source: secondary_id
APHP200044
Identifier Type: -
Identifier Source: org_study_id
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