N/A
Completed N=25
Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy
Source: ClinicalTrials.gov NCT05419999 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Posttraumatic Stress Disorder Checklist (PCL-5) — 44.30; 43.38; 22.51; 25.11 score on a scale
Summary
The primary objective of this study is to evaluate the safety, feasibility, and psychological and physiological treatment benefits of transcranial direct current stimulation (tDCS), a noninvasive brain stimulation technique, when delivered in combination with Written Exposure Therapy (WET), for posttraumatic stress disorder posttraumatic stress disorder (PTSD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Posttraumatic Stress Disorder Checklist (PCL-5) |
44.30; 43.38; 22.51; 25.11 | — |
| PRIMARY Number of Subjects That Completed All 5 WET Sessions |
12; 12 | — |
| SECONDARY Clinician Administer PTSD Scale-5 (CAPS-5) |
35.95; 35.08; 14.65; 15.89 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ) |
15.58; 15.54; 11.00; 10.66 | — |
| SECONDARY Generalize Anxiety Disorder-7 (GAD) |
15.00; 15.39; 10.30; 9.74 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals between the ages of 18 and 65 years old at time of screening.
- PTSD diagnosis as assessed by the Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
- Able to write, read, and speak English
Exclusion Criteria
- History of epilepsy or seizures.
- History of significant intracranial pathology (e.g., severe traumatic brain injury) or neurological disorder (e.g., Stroke, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Alzheimer's, Dementia, Parkinson's, and/or Huntington's).
- History of skin condition (e.g., eczema, psoriasis) where electrodes will be applied.
- Electronic implants in the body that could be susceptible to electrical current (e.g., cardiac pacemaker, cochlear implants, medical pump).
- Metallic objects other than dental appliances/fillings near the site of stimulation
- Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgement).
- Current moderate or severe substance use disorder.
- Suicidality and/or psychiatric risk requiring immediate intervention or a higher level of care than can be provided by the study treatment.
- Change in anticonvulsive or benzodiazepine medication regimen in the past month.
- History of adverse effects to previous tDCS or other brain stimulation technique.
- Concurrent engagement in another brain simulation technique or trauma-related psychotherapy for PTSD.
- Currently pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT05419999). 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.