Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation (TETT-STIM)

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

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 Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Device: rTMS 1Hz; Behavioral: psychoneurological assessment; Device: conductivity meter; Device: electrocardiogram; Device: rTMS 10Hz

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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	Behavioral: psychoneurological assessment; psychoneurological assessment; Device: conductivity meter; electrodermal conductance measure; Device: electrocardiogram; heart rate measure; Device: rTMS 10Hz; trauma exposure + repeated transcranial magnetic stimulation at 10Hz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Score at Clinician administered PTSD scale	Score at Clinician administered PTSD scale	inclusion ; 1 months; 3 months

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Wissam EL-HAGE, PhD, Chru Tours

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2016
• Primary Completion (Actual): April 17, 2020
• Study Completion (Actual): April 17, 2020

Study Registration Dates

• First Submitted: October 14, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Stress Disorders, Post-Traumatic; Repeated transcranial magnetic stimulation; trauma exposure
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: PHAO 15- WEH / TETT- STIM