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

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rTMS 1Hz
rTMS 10Hz
psychoneurological assessment
conductivity meter
electrocardiogram
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Stress Disorders, Post-Traumatic, trauma exposure, Repeated transcranial magnetic stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    rTMS 1Hz

    rTMS 10Hz

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Change from baseline Score at Clinician administered PTSD scale
    Score at Clinician administered PTSD scale

    Secondary Outcome Measures

    Change from baseline Score at PTSD Checklist (self-assessment)
    Score at PTSD Checklist (self-assessment) for severity of PTSD
    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
    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)
    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)
    Change from baseline heart rate
    heart rate
    Change from baseline electrodermal conductance
    electrodermal conductance measure
    Adverse effect
    Adverse effect

    Full Information

    First Posted
    October 14, 2015
    Last Updated
    July 8, 2020
    Sponsor
    University Hospital, Tours
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02584894
    Brief Title
    Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation
    Acronym
    TETT-STIM
    Official Title
    Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation : A Control Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 4, 2016 (Actual)
    Primary Completion Date
    April 17, 2020 (Actual)
    Study Completion Date
    April 17, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Tours

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Disorders, Post-Traumatic
    Keywords
    Stress Disorders, Post-Traumatic, trauma exposure, Repeated transcranial magnetic stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    rTMS 1Hz
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Arm Title
    rTMS 10Hz
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    rTMS 1Hz
    Intervention Description
    trauma exposure + repeated transcranial magnetic stimulation at 1Hz
    Intervention Type
    Device
    Intervention Name(s)
    rTMS 10Hz
    Intervention Description
    trauma exposure + repeated transcranial magnetic stimulation at 10Hz
    Intervention Type
    Behavioral
    Intervention Name(s)
    psychoneurological assessment
    Intervention Description
    psychoneurological assessment
    Intervention Type
    Device
    Intervention Name(s)
    conductivity meter
    Intervention Description
    electrodermal conductance measure
    Intervention Type
    Device
    Intervention Name(s)
    electrocardiogram
    Intervention Description
    heart rate measure
    Primary Outcome Measure Information:
    Title
    Change from baseline Score at Clinician administered PTSD scale
    Description
    Score at Clinician administered PTSD scale
    Time Frame
    inclusion ; 1 months; 3 months
    Secondary Outcome Measure Information:
    Title
    Change from baseline Score at PTSD Checklist (self-assessment)
    Description
    Score at PTSD Checklist (self-assessment) for severity of PTSD
    Time Frame
    inclusion ; 1 month; 3 months
    Title
    Change from baseline Score at PTSD Checklist (self-assessment) for different dimensions of PTSD
    Description
    Score at PTSD Checklist (self-assessment) for severity of different dimensions of PTSD
    Time Frame
    inclusion ; 1 month; 3 months
    Title
    Change from baseline Score at anxiety and depression item on Hamilton Anxiety Rating Scale (HAM-A)
    Description
    Score at anxiety and depression item on Hamilton Anxiety Rating Scale (HAM-A)
    Time Frame
    inclusion ; 1 month; 3 months
    Title
    Change from baseline Score at depression item on Hamilton Anxiety Rating Scale (HAM-A)
    Description
    Score at depression item on Hamilton Depression Rating Scale (HAM-D)
    Time Frame
    inclusion ; 1 month; 3 months
    Title
    Change from baseline heart rate
    Description
    heart rate
    Time Frame
    inclusion ; 1day ; 1 month, 3 months
    Title
    Change from baseline electrodermal conductance
    Description
    electrodermal conductance measure
    Time Frame
    inclusion ; 1day ; 1 month, 3 months
    Title
    Adverse effect
    Description
    Adverse effect
    Time Frame
    inclusion ; 1day ; 1 month, 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wissam EL-HAGE, PhD
    Organizational Affiliation
    CHRU Tours
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21963442
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22278745
    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.
    Results Reference
    background
    PubMed Identifier
    21971161
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20688488
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21623668
    Citation
    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.
    Results Reference
    background

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

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