Clinical trial NCT02584894: Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation
Official title: Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation : A Control Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Stress Disorders, Post-Traumatic
trauma exposure
Repeated transcranial magnetic stimulation
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline Score at Clinician administered PTSD scale
timeFrame: inclusion ; 1 months; 3 months
Secondary outcomes:
measure: Change from baseline Score at PTSD Checklist (self-assessment)
timeFrame: inclusion ; 1 month; 3 months
measure: Change from baseline Score at PTSD Checklist (self-assessment) for different dimensions of PTSD
timeFrame: inclusion ; 1 month; 3 months
measure: Change from baseline Score at anxiety and depression item on Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: inclusion ; 1 month; 3 months
measure: Change from baseline Score at depression item on Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: inclusion ; 1 month; 3 months
measure: Change from baseline heart rate
timeFrame: inclusion ; 1day ; 1 month, 3 months
measure: Change from baseline electrodermal conductance
timeFrame: inclusion ; 1day ; 1 month, 3 months
measure: Adverse effect
timeFrame: inclusion ; 1day ; 1 month, 3 months
Other outcomes:
Locations:
Study officials:
affiliation: CHRU TOURS
name: Wissam EL-HAGE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quide Y, Witteveen AB, El-Hage W, Veltman DJ, Olff M. Differences between effects of psychological versus pharmacological treatments on functional and morphological brain alterations in anxiety disorders and major depressive disorder: a systematic review. Neurosci Biobehav Rev. 2012 Jan;36(1):626-44. doi: 10.1016/j.neubiorev.2011.09.004. Epub 2011 Sep 24.
citation: Tapia G, Clarys D, Bugaiska A, El-Hage W. Recollection of negative information in posttraumatic stress disorder. J Trauma Stress. 2012 Feb;25(1):120-3. doi: 10.1002/jts.21659. Epub 2012 Jan 25.
citation: Landre L, Destrieux C, Andersson F, Barantin L, Quide Y, Tapia G, Jaafari N, Clarys D, Gaillard P, Isingrini M, El-Hage W. Working memory processing of traumatic material in women with posttraumatic stress disorder. J Psychiatry Neurosci. 2012 Feb;37(2):87-94. doi: 10.1503/jpn.100167.
citation: Landre L, Destrieux C, Baudry M, Barantin L, Cottier JP, Martineau J, Hommet C, Isingrini M, Belzung C, Gaillard P, Camus V, El Hage W. Preserved subcortical volumes and cortical thickness in women with sexual abuse-related PTSD. Psychiatry Res. 2010 Sep 30;183(3):181-6. doi: 10.1016/j.pscychresns.2010.01.015. Epub 2010 Aug 4.
citation: Jaafari N, Rachid F, Rotge JY, Polosan M, El-Hage W, Belin D, Vibert N, Pelissolo A. Safety and efficacy of repetitive transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder: a review. World J Biol Psychiatry. 2012 Mar;13(3):164-77. doi: 10.3109/15622975.2011.575177. Epub 2011 May 30.