Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation

Study Overview
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Brief Summary
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The aim of this study is to assess the efficacy in PTSD treatment of concomitant voluntary reactivation of personal traumatic memories with neuromodulation of the right dorsolateral prefrontal cortex using 10Hz rTMS, compared to 1Hz rTMS, during 2 weeks.

Detailed Description
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Post-Traumatic Stress Disorder (PTSD) is characterized by intrusive and persistent memory of past result from an event causing or able to cause death, be a threat of death, a severe injury or constitute a threat for physical integrity. It is a frequent disorder in general population (8%). In France, The most frequent traumatic events causing PTSD are serious accidents, rape, physical assaults, violence, etc. PTSD treatment involves antidepressant and cognitive and behavioural psychotherapy, which encourage exposure to elements that remind the trauma (memories, circumstances), with the objective of reducing the fear associated with the traumatic memories. Innovative therapeutic strategies aim to improve the psychotherapeutic effect with enhancement drugs or using neuromodulatory techniques, such as repeated transcranial magnetic stimulation (rTMS). The aim of this study is to assess the efficacy in PTSD treatment of concomitant voluntary reactivation of personal traumatic memories with neuromodulation of the right dorsolateral prefrontal cortex using 10Hz rTMS, compared to 1Hz rTMS, during 2 weeks.

Official Title
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Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation : A Control Randomized Study

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Device: rTMS 1Hz
* Device: rTMS 10Hz
* Behavioral: psychoneurological assessment
* Device: conductivity meter
* Device: electrocardiogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PCLS score >40 Able to give his written informed consent Not participating another study Affiliation to a social security system Having a PTSD for 3 months No treatment modification for 4 weeks (Psychotropic treatment or structured psychotherapy) Exclusion Criteria: Partially deaf with equipment people with identified neurological disease people with addiction to psychoactive substance people who can't conform to tests people having a contraindication for rTMS (cochlear implant ) people suffering from chronicle or acute delusional disorder any circumstances making the people unable to understood nature, aim or consequences of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: rTMS 1Hz<br>Subjects have 8 session of trauma exposure with repeated transcranial magnetic stimulation (rTMS) at 1Hz on dorsolateral prefrontal cortex (1Hz rTMS is describe in the literature to have no effect on the dorsolateral prefrontal cortex). psychoneurological assessment. Electrodermal conductance measure With conductivity meter . Heart rate measure With electrocardiogram | Device: rTMS 1Hz<br>* trauma exposure + repeated transcranial magnetic stimulation at 1Hz<br>Behavioral: psychoneurological assessment<br>* psychoneurological assessment<br>Device: conductivity meter<br>* electrodermal conductance measure<br>Device: electrocardiogram<br>* heart rate measure<br>|
| Experimental: rTMS 10Hz<br>Subjects have 8 session of trauma exposure with repeated transcranial magnetic stimulation (rTMS) at 10Hz on dorsolateral prefrontal cortex (10Hz rTMS is describe in the literature to have effect on the dorsolateral prefrontal cortex). psychoneurological assessment. Electrodermal conductance measure With conductivity meter. Heart rate measure with electrocardiogram | Device: rTMS 10Hz<br>* trauma exposure + repeated transcranial magnetic stimulation at 10Hz<br>Behavioral: psychoneurological assessment<br>* psychoneurological assessment<br>Device: conductivity meter<br>* electrodermal conductance measure<br>Device: electrocardiogram<br>* heart rate measure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Score at Clinician administered PTSD scale | Score at Clinician administered PTSD scale | inclusion ; 1 months; 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Score at PTSD Checklist (self-assessment) | Score at PTSD Checklist (self-assessment) for severity of PTSD | inclusion ; 1 month; 3 months | 
| Change from baseline Score at PTSD Checklist (self-assessment) for different dimensions of PTSD | Score at PTSD Checklist (self-assessment) for severity of different dimensions of PTSD | inclusion ; 1 month; 3 months | 
| Change from baseline Score at anxiety and depression item on Hamilton Anxiety Rating Scale (HAM-A) | Score at anxiety and depression item on Hamilton Anxiety Rating Scale (HAM-A) | inclusion ; 1 month; 3 months | 
| Change from baseline Score at depression item on Hamilton Anxiety Rating Scale (HAM-A) | Score at depression item on Hamilton Depression Rating Scale (HAM-D) | inclusion ; 1 month; 3 months | 
| Change from baseline heart rate | heart rate | inclusion ; 1day ; 1 month, 3 months | 
| Change from baseline electrodermal conductance | electrodermal conductance measure | inclusion ; 1day ; 1 month, 3 months | 
| Adverse effect | Adverse effect | inclusion ; 1day ; 1 month, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Disorders, Post-Traumatic, trauma exposure, Repeated transcranial magnetic stimulation