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

NCT02900053 | Completed

• 1 other identifier: PHRI15-JBC/T-TREAt
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Evolution of PTSD symptoms

  Evolution of PTSD symptoms defined by difference of PTSD severity score measured by Clinician Administered PTSD Scale ( CAPS-5, structured interview)

  between initial evaluation at J0 before beginning of treatment and follow-up evaluation at 3 month after the end of treatment

Secondary Outcomes (10)

• Evolution of PTSD severity score

  between initial evaluation at J0 before beginning of treatment and follow-up evaluation at 1 month after the end of treatment

• Evolution of PTSD severity score

  between initial evaluation at J0 before beginning of treatment, follow-up evaluation at 1 month, follow-up evaluation at 3 month after the end of treatment

• Evolution of severity of different PTSD under-dimensions

  between initial evaluation at J0 before beginning of treatment, follow-up evaluation at 1 month, follow-up evaluation at 3 month after the end of treatment

• Evolution of comorbid depressive symptoms

  between initial evaluation at J0 before beginning of treatment, follow-up evaluation at 1 month, follow-up evaluation at 3 month after the end of treatment

• Evolution of comorbid anxious symptoms

  between initial evaluation at J0 before beginning of treatment, follow-up evaluation at 1 month, follow-up evaluation at 3 month after the end of treatment

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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

Device: tDCS

Arm 2

PLACEBO COMPARATOR

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

Device: Placebo tDCS

Interventions

tDCS DEVICE

tDCS for transcranial Direct-Current Stimulation

Arm 1

Placebo tDCS DEVICE

Placebo tDCS for transcranial Direct-Current Stimulation

Arm 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (5)

CHU Angers

Angers, 49933, France

Location

CHU Nantes

Nantes, 44000, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

CHU Rennes

Rennes, 35703, France

Location

CHU Tours

Tours, 37044, France

Location

Related Publications (1)

• 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.

  PMID: 38704084 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jean-Baptiste Courtine, MD

  CHRU TOURS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 14, 2016
• Study Start: January 1, 2017
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 26, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)