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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Stress Disorders, Post-Traumatic

Treatments: Device: conductivity meter; Device: electrocardiogram; Behavioral: psychoneurological assessment; Device: rTMS 10Hz; Device: rTMS 1Hz

Study type: Interventional

Funder types: Other

Identifiers

NCT02584894

PHAO 15- WEH / TETT- STIM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 2 patient groups, including a placebo group

rTMS 1Hz

Placebo Comparator group

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

Treatment:

Behavioral: psychoneurological assessment

Device: rTMS 1Hz

Device: conductivity meter

Device: electrocardiogram

rTMS 10Hz

Experimental group

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

Treatment:

Behavioral: psychoneurological assessment

Device: rTMS 10Hz

Device: conductivity meter

Device: electrocardiogram