Stress Disorders, Post-Traumatic Clinical Trial
— TETT-STIMOfficial title:
Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation : A Control Randomized Study
Verified date | July 2020 |
Source | University Hospital, Tours |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | April 17, 2020 |
Est. primary completion date | April 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University Hospital, Tours |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline Score at Clinician administered PTSD scale | Score at Clinician administered PTSD scale | inclusion ; 1 months; 3 months | |
Secondary | Change from baseline Score at PTSD Checklist (self-assessment) | Score at PTSD Checklist (self-assessment) for severity of PTSD | inclusion ; 1 month; 3 months | |
Secondary | Change from baseline Score at PTSD Checklist (self-assessment) for different dimensions of PTSD | Score at PTSD Checklist (self-assessment) for severity of different dimensions of PTSD | inclusion ; 1 month; 3 months | |
Secondary | Change from baseline Score at anxiety and depression item on Hamilton Anxiety Rating Scale (HAM-A) | Score at anxiety and depression item on Hamilton Anxiety Rating Scale (HAM-A) | inclusion ; 1 month; 3 months | |
Secondary | Change from baseline Score at depression item on Hamilton Anxiety Rating Scale (HAM-A) | Score at depression item on Hamilton Depression Rating Scale (HAM-D) | inclusion ; 1 month; 3 months | |
Secondary | Change from baseline heart rate | heart rate | inclusion ; 1day ; 1 month, 3 months | |
Secondary | Change from baseline electrodermal conductance | electrodermal conductance measure | inclusion ; 1day ; 1 month, 3 months | |
Secondary | Adverse effect | Adverse effect | inclusion ; 1day ; 1 month, 3 months |
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