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Completed

NCT Number: NCT02584894

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rTMS 1Hz

Device

trauma exposure + repeated transcranial magnetic stimulation at 1Hz

rTMS 10Hz

Device

trauma exposure + repeated transcranial magnetic stimulation at 10Hz

psychoneurological assessment

Behavioral

psychoneurological assessment

conductivity meter

Device

electrodermal conductance measure

Electrocardiogram

Device

heart rate measure

Primary outcomes

  1. Change from baseline Score at Clinician administered PTSD scale

    Time frame: inclusion ; 1 months; 3 months

    Score at Clinician administered PTSD scale

Secondary outcomes

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

    Time frame: inclusion ; 1 month; 3 months

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

  2. Change from baseline Score at PTSD Checklist (self-assessment) for different dimensions of PTSD

    Time frame: inclusion ; 1 month; 3 months

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

  3. Change from baseline Score at anxiety and depression item on Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: inclusion ; 1 month; 3 months

    Score at anxiety and depression item on Hamilton Anxiety Rating Scale (HAM-A)

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

    Time frame: inclusion ; 1 month; 3 months

    Score at depression item on Hamilton Depression Rating Scale (HAM-D)

  5. Change from baseline heart rate

    Time frame: inclusion ; 1day ; 1 month, 3 months

    heart rate

  6. Change from baseline electrodermal conductance

    Time frame: inclusion ; 1day ; 1 month, 3 months

    electrodermal conductance measure

  7. Adverse effect

    Time frame: inclusion ; 1day ; 1 month, 3 months

    Adverse effect

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: TETT-STIM

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2015
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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