An interventional study of tDCS and Placebo tDCS in Post-traumatic Stress Disorder, sponsored by University Hospital, Tours. Completed at 5 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by University Hospital, Tours · Not applicable, Interventional, and Treatment
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.
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.
This study's enrollment of 63 is close to the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cerebral modulation using tDCS (transcranial Direct-Current Stimulation) associated with repetitive traumatic exposure using a personal traumatic script
Device: tDCS
Placebo cerebral modulation using sham-tDCS associated with repetitive traumatic exposure using a personal traumatic script
Device: Placebo tDCS
tDCS for transcranial Direct-Current Stimulation
Placebo tDCS for transcranial Direct-Current Stimulation
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)
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 severity score
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 physiological response
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
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 clinical tolerance
Evolution of clinical tolerance to this therapeutic procedure by Brunoni questionnaire (nausea, headache, rash, skin redness, tingling, dizziness)
Time frame: After each session
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic→
University Hospital, Tours