NCT02584894

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 4, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2020

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

4.3 years

First QC Date

October 14, 2015

Last Update Submit

June 8, 2026

Conditions

Stress Disorders, Post-Traumatic

Keywords

Stress Disorders, Post-Traumatictrauma exposureRepeated transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Score at Clinician administered PTSD scale

    Score at Clinician administered PTSD scale

    inclusion ; 1 months; 3 months

Secondary Outcomes (7)

  • Change from baseline Score at PTSD Checklist (self-assessment)

    inclusion ; 1 month; 3 months

  • Change from baseline Score at PTSD Checklist (self-assessment) for 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)

    inclusion ; 1 month; 3 months

  • Change from baseline Score at depression item on Hamilton Anxiety Rating Scale (HAM-A)

    inclusion ; 1 month; 3 months

  • Change from baseline heart rate

    inclusion ; 1day ; 1 month, 3 months

  • +2 more secondary outcomes

Study Arms (2)

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

Device: rTMS 1HzBehavioral: psychoneurological assessmentDevice: conductivity meterDevice: 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

Device: rTMS 10HzBehavioral: psychoneurological assessmentDevice: conductivity meterDevice: electrocardiogram

Interventions

rTMS 1HzDEVICE

trauma exposure + repeated transcranial magnetic stimulation at 1Hz

rTMS 1Hz
rTMS 10HzDEVICE

trauma exposure + repeated transcranial magnetic stimulation at 10Hz

rTMS 10Hz
conductivity meterDEVICE

electrodermal conductance measure

rTMS 10HzrTMS 1Hz
electrocardiogramDEVICE

heart rate measure

rTMS 10HzrTMS 1Hz
psychoneurological assessmentBEHAVIORAL

psychoneurological assessment

rTMS 10HzrTMS 1Hz

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 21963442BACKGROUND

  • 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.

    PMID: 22278745BACKGROUND

  • 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.

    PMID: 21971161BACKGROUND

  • 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.

    PMID: 20688488BACKGROUND

  • 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.

    PMID: 21623668BACKGROUND

  • 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.

    PMID: 35667770RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Wissam EL-HAGE, PhD

    CHRU TOURS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 23, 2015

Study Start

January 4, 2016

Primary Completion

April 17, 2020

Study Completion

April 17, 2020

Last Updated

June 11, 2026

Record last verified: 2026-06