Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation : A Control Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Disorders, Post-Traumatic
- Sponsor
- University Hospital, Tours
- Enrollment
- 39
- Primary Endpoint
- Change from baseline Score at Clinician administered PTSD scale
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change from baseline Score at Clinician administered PTSD scale
Time Frame: inclusion ; 1 months; 3 months
Score at Clinician administered PTSD scale
Secondary Outcomes
- Change from baseline heart rate(inclusion ; 1day ; 1 month, 3 months)
- Change from baseline Score at PTSD Checklist (self-assessment)(inclusion ; 1 month; 3 months)
- Adverse effect(inclusion ; 1day ; 1 month, 3 months)
- Change from baseline Score at PTSD Checklist (self-assessment) for 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)(inclusion ; 1 month; 3 months)
- Change from baseline Score at depression item on Hamilton Anxiety Rating Scale (HAM-A)(inclusion ; 1 month; 3 months)
- Change from baseline electrodermal conductance(inclusion ; 1day ; 1 month, 3 months)