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Post-traumatic Stress Disorder Treatment Using Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy : a Two-arm Randomized Controlled Multicentric Study.

NCT ID: NCT02900053

Last Updated: 2025-12-26

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-10-01

Brief Summary

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Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that can develop after exposure to a terrifying event or ordeal in which there was the potential for or actual occurrence of grave physical harm. Traumatic events that may trigger PTSD include violent personal assaults, natural or human-caused disasters, accidents, and military combat. People with PTSD have persistent frightening thoughts and memories of their ordeal, may experience sleep problems, feel detached or numb, or be easily startled. Its lifetime prevalence is quite high, with 7-8% in various studies and 4% in french studies.

The current PTSD treatment usually involves antidepressants as serotonin-specific reuptake inhibitors (SSRIs) and Cognitive Behavioral Therapies, such as exposure therapy to trauma-linked elements (memories, feelings and thoughts) so the fear associated to the traumatic event can decrease. But the therapeutic response stays partial, even combining these treatments.

To improve the PTSD treatment efficiency, innovative approaches are being explored like new drugs or cerebral stimulation. This project aims to assess the efficacy of a less known but promising therapeutic strategy for PTSD : the use of transcranial Direct-Current Stimulation (tDCS) to enhance the trauma-focused therapy results.

Detailed Description

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Conditions

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Post-traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Cerebral modulation using tDCS (transcranial Direct-Current Stimulation) associated with repetitive traumatic exposure using a personal traumatic script

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

tDCS for transcranial Direct-Current Stimulation

Arm 2

Placebo cerebral modulation using sham-tDCS associated with repetitive traumatic exposure using a personal traumatic script

Group Type PLACEBO_COMPARATOR

Placebo tDCS

Intervention Type DEVICE

Placebo tDCS for transcranial Direct-Current Stimulation

Interventions

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tDCS

tDCS for transcranial Direct-Current Stimulation

Intervention Type DEVICE

Placebo tDCS

Placebo tDCS for transcranial Direct-Current Stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Having a chronic PTSD (for more than 3 months and less than 10 years) without modification of SSRI long-term treatment for more than 4 weeks
* Between 18 and 65 years-old
* Effective contraception for women, or inability of procreate because of medical or surgical reasons
* Able to give his written informed consent
* Affiliation to a social security system
* Not participating to another study with psychoactive substance

Exclusion Criteria

* Partially-sighted or partially deaf person requiring equipment
* Person with brain injury or neurological disease (epileptic, tumoral, vascular, degenerative), diagnoses in personal history or recognized as hereditary
* Addiction to psychoactive substance for the last 6 months
* Any treatment which could interact with tDCS effects on cortical reactivity (citalopram, amphetamine, L-dopa, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan or other N-methyl-D-aspartate (NMDA) receptor antagonists, d-cycloserine, carbamazepine, flunarizine, calcium channel blockers)
* Pregnancy and lactation
* Any intracephalic metallic material
* Person who can't conform to tests instructions
* Person suffering from bipolar disorder, chronic or acute delusional disorder
* Any circumstances making the person unable to understand the trial features, purposes or consequences
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Baptiste Courtine, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU TOURS

Locations

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CHU Angers

Angers, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

CHU Poitiers

Poitiers, , France

Site Status

CHU Rennes

Rennes, , France

Site Status

CHU Tours

Tours, , France

Site Status

Countries

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France

References

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Eyraud N, Poupin P, Legrand M, Caille A, Sauvaget A, Bulteau S, Gohier B, Harika-Germaneau G, Drapier D, Jaafari N, Bodic O, Brizard B, Gissot V, Belzung C, Courtine JB, El-Hage W. Combining trauma script exposure with tDCS to alleviate symptoms of posttraumatic stress disorder: A two-arm randomized sham-controlled multicenter trial. Brain Stimul. 2024 May-Jun;17(3):591-593. doi: 10.1016/j.brs.2024.04.018. Epub 2024 May 3. No abstract available.

Reference Type RESULT
PMID: 38704084 (View on PubMed)

Other Identifiers

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PHRI15-JBC/T-TREAt

Identifier Type: -

Identifier Source: org_study_id