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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-04

Study Completion Date

2020-04-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)

NCT00685152

Post-Traumatic Stress Disorder

COMPLETED NA

High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in PTSD

NCT02873299

PTSD, Post Traumatic Stress Disorder

COMPLETED EARLY_PHASE1

rTMS in the Treatment of PTSD

NCT01806168

Post-traumatic Stress Disorder (PTSD)

COMPLETED NA

Transcranial Magnetic Stimulation (TMS) to Treat mTBI and PTSD

NCT02458521

Traumatic Brain Injury Post-Traumatic Stress Disorder

UNKNOWN NA

Repetitive Transcranial Magnetic Stimulation With Or Without Traumatic Stimuli in Post Traumatic Stress Disorder (PTSD)

NCT01196624

Flashbacks Posttraumatic Stress Disorder

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Disorders, Post-Traumatic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type PLACEBO_COMPARATOR

rTMS 1Hz

Intervention Type DEVICE

trauma exposure + repeated transcranial magnetic stimulation at 1Hz

psychoneurological assessment

Intervention Type BEHAVIORAL

psychoneurological assessment

conductivity meter

Intervention Type DEVICE

electrodermal conductance measure

electrocardiogram

Intervention Type DEVICE

heart rate measure

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

Group Type EXPERIMENTAL

rTMS 10Hz

Intervention Type DEVICE

trauma exposure + repeated transcranial magnetic stimulation at 10Hz

psychoneurological assessment

Intervention Type BEHAVIORAL

psychoneurological assessment

conductivity meter

Intervention Type DEVICE

electrodermal conductance measure

electrocardiogram

Intervention Type DEVICE

heart rate measure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rTMS 1Hz

trauma exposure + repeated transcranial magnetic stimulation at 1Hz

Intervention Type DEVICE

rTMS 10Hz

trauma exposure + repeated transcranial magnetic stimulation at 10Hz

Intervention Type DEVICE

psychoneurological assessment

Intervention Type BEHAVIORAL

conductivity meter

electrodermal conductance measure

Intervention Type DEVICE

electrocardiogram

heart rate measure

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No