Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation
- Conditions
- Stress Disorders, Post-Traumatic
- Interventions
- Device: rTMS 1HzDevice: rTMS 10HzBehavioral: psychoneurological assessmentDevice: conductivity meterDevice: electrocardiogram
- Registration Number
- NCT02584894
- Lead Sponsor
- University Hospital, Tours
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rTMS 1Hz rTMS 1Hz 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 rTMS 10Hz rTMS 10Hz 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 rTMS 1Hz psychoneurological assessment 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 rTMS 1Hz conductivity meter 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 rTMS 1Hz electrocardiogram 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 rTMS 10Hz psychoneurological assessment 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 rTMS 10Hz conductivity meter 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 rTMS 10Hz electrocardiogram 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
- Primary Outcome Measures
Name Time Method Change from baseline Score at Clinician administered PTSD scale inclusion ; 1 months; 3 months Score at Clinician administered PTSD scale
- Secondary Outcome Measures
Name Time Method Change from baseline heart rate inclusion ; 1day ; 1 month, 3 months heart rate
Change from baseline Score at PTSD Checklist (self-assessment) inclusion ; 1 month; 3 months Score at PTSD Checklist (self-assessment) for severity of PTSD
Adverse effect inclusion ; 1day ; 1 month, 3 months Adverse effect
Change from baseline Score at PTSD Checklist (self-assessment) for different dimensions of PTSD inclusion ; 1 month; 3 months Score at PTSD Checklist (self-assessment) for severity of different dimensions of PTSD
Change from baseline Score at anxiety and depression item on Hamilton Anxiety Rating Scale (HAM-A) inclusion ; 1 month; 3 months Score at anxiety and depression item on Hamilton Anxiety Rating Scale (HAM-A)
Change from baseline Score at depression item on Hamilton Anxiety Rating Scale (HAM-A) inclusion ; 1 month; 3 months Score at depression item on Hamilton Depression Rating Scale (HAM-D)
Change from baseline electrodermal conductance inclusion ; 1day ; 1 month, 3 months electrodermal conductance measure