Stress Disorders, Post-Traumatic
Conditions
Keywords
Stress Disorders, Post-Traumatic, trauma exposure, Repeated transcranial magnetic stimulation
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.
Interventions
DEVICErTMS 1Hz
trauma exposure + repeated transcranial magnetic stimulation at 1Hz
DEVICErTMS 10Hz
trauma exposure + repeated transcranial magnetic stimulation at 10Hz
BEHAVIORALpsychoneurological assessment
psychoneurological assessment
DEVICEconductivity meter
electrodermal conductance measure
DEVICEelectrocardiogram
heart rate measure
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Score at Clinician administered PTSD scale | inclusion ; 1 months; 3 months | Score at Clinician administered PTSD scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Score at PTSD Checklist (self-assessment) | inclusion ; 1 month; 3 months | Score at PTSD Checklist (self-assessment) for severity of PTSD |
| 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 heart rate | inclusion ; 1day ; 1 month, 3 months | heart rate |
| Change from baseline electrodermal conductance | inclusion ; 1day ; 1 month, 3 months | electrodermal conductance measure |
| Adverse effect | inclusion ; 1day ; 1 month, 3 months | Adverse effect |
Contacts
PRINCIPAL_INVESTIGATORWissam EL-HAGE, PhD
CHRU TOURS
Outcome results
None listed