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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Post-traumatic Stress Disorder

Treatments: Device: tDCS; Device: Placebo tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02900053

PHRI15-JBC/T-TREAt

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

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

Treatment:

Device: tDCS

Arm 2

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo tDCS