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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. (T-TREAt)

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ClinicalTrials.gov Identifier: NCT02900053
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

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.


Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Device: tDCS Device: Placebo tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1
Cerebral modulation using tDCS (transcranial Direct-Current Stimulation) associated with repetitive traumatic exposure using a personal traumatic script
Device: tDCS
tDCS for transcranial Direct-Current Stimulation

Placebo Comparator: Arm 2
Placebo cerebral modulation using sham-tDCS associated with repetitive traumatic exposure using a personal traumatic script
Device: Placebo tDCS
Placebo tDCS for transcranial Direct-Current Stimulation




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900053


Contacts
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Contact: Jean-Baptiste Courtine, MD +33247474747 jean.courtine@univ-tours.fr

Locations
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France
CHU Angers Not yet recruiting
Angers, France, 49933
Contact: Benedicte Gohier, PhD    +33241353244    be.gohier@chu-angers.fr   
Principal Investigator: Benedicte Gohier, PhD         
CHU Nantes Not yet recruiting
Nantes, France, 44000
Contact: Anne Sauvaget, MD    +33240084795    anne.sauvaget@chu-nantes.fr   
Principal Investigator: Anne Sauvaget, MD         
CHU Poitiers Recruiting
Poitiers, France, 86021
Contact: Nematollah Jaafari, PhD    +33549445802    nemat.jaafari@ch-poitiers.fr   
Principal Investigator: Nematollah Jaafari, PhD         
CHU Rennes Not yet recruiting
Rennes, France, 35703
Contact: Dominique Drappier, PhD    +33299333900    d.drapier@ch-guillaumeregnier.fr   
Principal Investigator: Dominique Drappier, PhD         
CHU Tours Recruiting
Tours, France, 37044
Contact: Jean-Baptiste Courtine, MD    +33247474747    jean.courtine@univ-tours.fr   
Principal Investigator: Jean-Baptiste Courtine, MD         
Sub-Investigator: Wissam El-Hage, PhD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: Jean-Baptiste Courtine, MD CHRU Tours

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02900053     History of Changes
Other Study ID Numbers: PHRI15-JBC/T-TREAt
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders