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Stress Disorders, Post-TraumaticTETT-STIMNCT02584894

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

A study testing rTMS 1Hz, rTMS 10Hz and psychoneurological assessment in people with Stress Disorders, Post-Traumatic, run by University Hospital, Tours.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Stress Disorders, Post-Traumatic
What is being tested?
rTMS 1Hz, rTMS 10Hz and psychoneurological assessment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
No sites listed yet
Study dates
4 Jan 2016to 17 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

About this study

Official title: 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.

Read the 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.

Being tested
rTMS 1Hz, rTMS 10Hz, psychoneurological assessment, conductivity meter, electrocardiogram
Keywords
Stress Disorders, Post-Traumatic, trauma exposure, Repeated transcranial magnetic stimulation
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMS 1HzDevice

    trauma exposure + repeated transcranial magnetic stimulation at 1Hz

  • rTMS 10HzDevice

    trauma exposure + repeated transcranial magnetic stimulation at 10Hz

  • psychoneurological assessmentBehavioural

    psychoneurological assessment

  • conductivity meterDevice

    electrodermal conductance measure

  • electrocardiogramDevice

    heart rate measure

Study groups in NCT02584894
Study groupRoleWhat they receive
rTMS 1HzPlacebo comparatorSubjects 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
Receives: Device: rTMS 1Hz; Behavioral: psychoneurological assessment; Device: conductivity meter; Device: electrocardiogram
rTMS 10HzExperimentalSubjects 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
Receives: Device: rTMS 10Hz; Behavioral: psychoneurological assessment; Device: conductivity meter; Device: electrocardiogram

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Score at Clinician administered PTSD scale

    Score at Clinician administered PTSD scale

    Measured: inclusion ; 1 months; 3 months

Secondary outcomes (7)

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

    Score at PTSD Checklist (self-assessment) for severity of PTSD

    Measured: inclusion ; 1 month; 3 months

  2. 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

    Measured: inclusion ; 1 month; 3 months

  3. 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)

    Measured: inclusion ; 1 month; 3 months

  4. 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)

    Measured: inclusion ; 1 month; 3 months

  5. Change from baseline heart rate

    heart rate

    Measured: inclusion ; 1day ; 1 month, 3 months

  6. Change from baseline electrodermal conductance

    electrodermal conductance measure

    Measured: inclusion ; 1day ; 1 month, 3 months

  7. Adverse effect

    Adverse effect

    Measured: inclusion ; 1day ; 1 month, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2015 (estimated)
  2. Study start4 Jan 2016
  3. Primary completion17 Apr 2020
  4. Study completion17 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02584894
Sponsor's protocol ID
PHAO 15- WEH / TETT- STIM
Acronym
TETT-STIM
Status last verified
Jun 2026
First submitted
14 Oct 2015
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21963442

  • 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.

    PubMed 22278745

  • 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.

    PubMed 21971161

  • 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.

    PubMed 20688488

  • 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.

    PubMed 21623668

  • 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.

    PubMed 35667770

Questions about this trial

What is this clinical trial studying?

A study testing rTMS 1Hz, rTMS 10Hz and psychoneurological assessment in people with Stress Disorders, Post-Traumatic, run by University Hospital, Tours.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Score at Clinician administered PTSD scale (time frame: inclusion ; 1 months; 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02584894, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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