Clinical trial NCT02900053: Post-traumatic Stress Disorder Treatment Using Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy : a Two-arm Randomized Controlled Multicentric Study.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evolution of PTSD symptoms
timeFrame: between initial evaluation at J0 before beginning of treatment and follow-up evaluation at 3 month after the end of treatment
Secondary outcomes:
measure: Evolution of PTSD severity score
timeFrame: between initial evaluation at J0 before beginning of treatment and follow-up evaluation at 1 month after the end of treatment
measure: Evolution of PTSD severity score
timeFrame: 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
measure: Evolution of severity of different PTSD under-dimensions
timeFrame: 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
measure: Evolution of comorbid depressive symptoms
timeFrame: 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
measure: Evolution of comorbid anxious symptoms
timeFrame: 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
measure: Evolution of quality of life symptoms
timeFrame: 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
measure: Evolution of quality of life symptoms
timeFrame: 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
measure: Evolution of cognitive functioning
timeFrame: 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
measure: Evolution of physiological response
timeFrame: between evaluation at rest before the first session, during the first and the last session of tDCS, and 3 months after the last session of treatment
measure: Evolution of clinical tolerance
timeFrame: After each session
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Nantes
country: France
facility: CHU Nantes
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: CHU Rennes
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHRU TOURS
name: Jean-Baptiste Courtine, MD
role: PRINCIPAL_INVESTIGATOR
References: