Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation

Stress Disorders, Post-Traumatic Clinical Trial

— TETT-STIM  

Official title:

Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation : A Control Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584894
• Other study ID #: PHAO 15- WEH / TETT- STIM
• Status: Completed
• Phase: N/A
• Start date: January 4, 2016
• Est. completion date: April 17, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Disease
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• rTMS 1Hz
trauma exposure + repeated transcranial magnetic stimulation at 1Hz
• rTMS 10Hz
trauma exposure + repeated transcranial magnetic stimulation at 10Hz

Behavioral:
• psychoneurological assessment
psychoneurological assessment

Device:
• conductivity meter
electrodermal conductance measure
• electrocardiogram
heart rate measure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

References & Publications (5)

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

Outcome

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