N/A
Completed N=55
tDCS Plus Virtual Reality for PTSD
Source: ClinicalTrials.gov NCT03372460 ↗Enrolled (actual)
55
Serious AEs
7.4%
Results posted
Aug 2024
Primary outcomePrimary: Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score — 48.6; 45.0; 38.5; 41.3 score on a scale
Summary
This study tests the efficacy of combining non-invasive brain stimulation, called transcranial direct current stimulation (tDCS), with virtual reality exposure as a treatment for Veterans with chronic posttraumatic stress disorder (PTSD). Investigators tested whether this intervention improves PTSD symptoms and improves quality of life. Results from this study may be used to develop a new non-medication approach to treating chronic PTSD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score |
48.6; 45.0; 38.5; 41.3; 36.0; 38.9 | — |
| PRIMARY Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) |
35.9; 39.2; 39.2; 41.6; 40.7; 41.0 | — |
| PRIMARY Psychophysiology (Skin Conductance Reactivity; SCR) |
0.742; 0.64; 0.596; 0.503; 0.48; 0.539 | — |
| SECONDARY Inventory of Depressive Symptomatology Self-Report (IDSSR) |
41.6; 38.6; 35.5; 35.3; 34.2; 34.8 | — |
| SECONDARY Social and Occupational Function Scale (SOFAS) |
40.5; 43.0; 47.2; 48.0; 53.1; 54.1 | — |
| SECONDARY Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) |
44.8; 40.5; 40.4; 37.1; 34.1; 36.1 | — |
Eligibility Criteria
Inclusion Criteria
- Must be a Veteran
- Located in the greater Providence and Boston areas
- Have a diagnosis of chronic PTSD, meeting DSM-5 criteria
- If in treatment, symptomatic despite ongoing stable treatment regimens for at least 6 weeks prior to study procedures.
- Willing and able to comply with all study related procedures and visits
- Capable of independently reading and understanding study materials and providing informed consent.
Exclusion Criteria
Contraindications to MRI or tDCS, including:
- Implanted device (e.g., deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord.
- Skin lesions at the site of stimulation that may increase conductance (e.g., vascular moles or angiomas)
- Pregnancy/lactation, or planning to become pregnant during the study
- Lifetime history of moderate or severe traumatic brain injury (TBI)
- Current unstable medical conditions
- Current (or past if appropriate) significant neurological disorder, or lifetime history of a) seizure disorder b) primary or secondary CNS tumors c) stroke or d) cerebral aneurysm.
Other exclusions:
- Primary psychotic disorder
- Bipolar I disorder
- Active moderate/severe substance use disorders (within the last month, excluding nicotine/caffeine)
- Active suicidal intent or plan as detected on screening instruments or in the investigative team's judgment is likely to attempt suicide within 6 months
- Other conditions or circumstances that, in the opinion of the investigator team, have the potential to prevent completion and/or have a confounding effect on outcome assessments.
Data sourced from ClinicalTrials.gov (NCT03372460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.