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Completed

NCT Number: NCT02900053

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

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.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Device

tDCS for transcranial Direct-Current Stimulation

Placebo tDCS

Device

Placebo tDCS for transcranial Direct-Current Stimulation

Primary outcomes

  1. Evolution of PTSD symptoms

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

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

Secondary outcomes

  1. Evolution of PTSD severity score

    Time frame: 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 (measured with CAPS-5) between initial evaluation at J0 before beginning of treatment and follow-up evaluation at 1 month after the end of treatment

  2. Evolution of PTSD severity score

    Time frame: 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 PTSD severity score, measured by an auto-questionnaire (PTSD Checklist or Post-Traumatic CheckList Scale (PCL-5)), 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

  3. Evolution of severity of different PTSD under-dimensions

    Time frame: 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 (intrusive symptoms, evasion symptoms, mood and cognitive symptoms, reactivity and activation symptoms) as measured by CAPS-5 (structured interview) and PCL-5 (auto-questionnaire) 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

  4. Evolution of comorbid depressive symptoms

    Time frame: 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 measured by Beck depression inventory (BDI), abridged version ; auto-questionnaire) 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

  5. Evolution of comorbid anxious symptoms

    Time frame: 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 measured by avec la State-Trait Anxiety Inventory (STAI-A ; auto-questionnaire) 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

  6. Evolution of quality of life symptoms

    Time frame: 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 quality of life symptoms as measured by World Health Organization Quality Of Life abridged version (WHOQOL-BREF ; auto-questionnaire) 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

  7. Evolution of quality of life symptoms

    Time frame: 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 quality of life symptoms as measured by Global Functioning Evaluation scale (EGF) 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

  8. Evolution of cognitive functioning

    Time frame: 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 cognitive functioning as measured by Stroop test with emotional variant and n-back test 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

  9. Evolution of physiological response

    Time frame: 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

    Evolution of physiological response as measured by cutaneous conductance and cardiac and respiratory frequencies 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

  10. Evolution of clinical tolerance

    Time frame: After each session

    Evolution of clinical tolerance to this therapeutic procedure by Brunoni questionnaire (nausea, headache, rash, skin redness, tingling, dizziness)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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

Acronym: T-TREAt

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2016
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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