TETT-STIM: Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 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 |
Device: rTMS 1Hz
trauma exposure + repeated transcranial magnetic stimulation at 1Hz
Behavioral: psychoneurological assessment
psychoneurological assessment
Device: conductivity meter
electrodermal conductance measure
Device: electrocardiogram
heart rate measure
|
| Experimental: 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 |
Device: rTMS 10Hz
trauma exposure + repeated transcranial magnetic stimulation at 10Hz
Behavioral: psychoneurological assessment
psychoneurological assessment
Device: conductivity meter
electrodermal conductance measure
Device: electrocardiogram
heart rate measure
|
Outcome Measures
Primary Outcome Measures
- Change from baseline Score at Clinician administered PTSD scale [inclusion ; 1 months; 3 months]
Score at Clinician administered PTSD scale
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
PCLS score >40
-
Able to give his written informed consent
-
Not participating another study
-
Affiliation to a social security system
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Tours
Investigators
- Principal Investigator: Wissam EL-HAGE, PhD, CHRU Tours
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- Landré L, Destrieux C, Andersson F, Barantin L, Quidé 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.
- Landré 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.
- Quidé 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. Review.
- 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.
- PHAO 15- WEH / TETT- STIM