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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS 1Hz | Placebo Comparator | 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 |
|
| rTMS 10Hz | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS 1Hz | Device | trauma exposure + repeated transcranial magnetic stimulation at 1Hz |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Score at Clinician administered PTSD scale | Score at Clinician administered PTSD scale | inclusion ; 1 months; 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Score at PTSD Checklist (self-assessment) | Score at PTSD Checklist (self-assessment) for severity of PTSD | inclusion ; 1 month; 3 months |
| Change from baseline Score at PTSD Checklist (self-assessment) for different dimensions of PTSD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wissam EL-HAGE, PhD | CHRU TOURS | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21963442 | Background | 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. | |
| 22278745 |
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| rTMS 10Hz |
| Device |
trauma exposure + repeated transcranial magnetic stimulation at 10Hz |
|
| psychoneurological assessment | Behavioral | psychoneurological assessment |
|
| conductivity meter | Device | electrodermal conductance measure |
|
| electrocardiogram | Device | heart rate measure |
|
Score at PTSD Checklist (self-assessment) for severity of 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) | 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) | Score at depression item on Hamilton Depression Rating Scale (HAM-D) | inclusion ; 1 month; 3 months |
| Change from baseline heart rate | heart rate | inclusion ; 1day ; 1 month, 3 months |
| Change from baseline electrodermal conductance | electrodermal conductance measure | inclusion ; 1day ; 1 month, 3 months |
| Adverse effect | Adverse effect | inclusion ; 1day ; 1 month, 3 months |
| 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. |
| 21971161 | Background | 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. |
| 20688488 | Background | 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. |
| 21623668 | Background | 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. |
| 35667770 | Result | Thierree S, Raulin-Briot M, Legrand M, Le Gouge A, Vancappel A, Tudorache AC, Brizard B, Clarys D, Caille A, El-Hage W. Combining Trauma Script Exposure With rTMS to Reduce Symptoms of Post-Traumatic Stress Disorder: Randomized Controlled Trial. Neuromodulation. 2022 Jun;25(4):549-557. doi: 10.1111/ner.13505. Epub 2021 Aug 17. |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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