Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy

Safety, Feasibility, and Benefits of Transcranial Direct Current Stimulation (tDCS) in Human Subjects With Posttraumatic Stress Disorder (PTSD) Receiving an Exposure-based, Behavioral Therapy

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).

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Device: Soterix 1x1 tDCS mini CT; Behavioral: Written Exposure Therapy (WET); Other: Sham Soterix 1x1 tDCS Mini CT

Detailed Description

While the potential for non-invasive brain stimulation is exciting, research is needed to determine the safety, feasibility, and benefits of non-invasive brain stimulation in human subjects with PTSD. Towards this end, the study team will conduct a single-blind randomized controlled pilot study of transcranial direct current stimulation (tDCS) vs. a sham condition in a sample of 40 adults with PTSD receiving 5 weekly sessions of Written Exposure Therapy (WET), an exposure-based, behavioral psychotherapy for PTSD.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individuals between the ages of 18 and 65 years old at time of screening.
2. PTSD diagnosis as assessed by the Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
3. Able to write, read, and speak English

Exclusion Criteria:

1. History of epilepsy or seizures.
2. 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).
3. History of skin condition (e.g., eczema, psoriasis) where electrodes will be applied.
4. Electronic implants in the body that could be susceptible to electrical current (e.g., cardiac pacemaker, cochlear implants, medical pump).
5. Metallic objects other than dental appliances/fillings near the site of stimulation
6. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgement).
7. Current moderate or severe substance use disorder.
8. Suicidality and/or psychiatric risk requiring immediate intervention or a higher level of care than can be provided by the study treatment.
9. Change in anticonvulsive or benzodiazepine medication regimen in the past month.
10. History of adverse effects to previous tDCS or other brain stimulation technique.
11. Concurrent engagement in another brain simulation technique or trauma-related psychotherapy for PTSD.
12. Currently pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS plus WET; Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)	Device: Soterix 1x1 tDCS mini CT; During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize.; Other Names: Transcranial Direct Current Stimulator; Behavioral: Written Exposure Therapy (WET); An exposure-based, behavioral psychotherapy for PTSD.
Sham Comparator: Sham plus WET; Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)	Behavioral: Written Exposure Therapy (WET); An exposure-based, behavioral psychotherapy for PTSD.; Other: Sham Soterix 1x1 tDCS Mini CT; Sham setting is used on the Soterix transcranial electrical stimulator; Other Names: Sham Transcranial Direct Current Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posttraumatic Stress Disorder Checklist (PCL-5)	The PCL-5 is a 20-item self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. The PCL-5 is currently available and has been shown to have good psychometric properties. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past two weeks (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). This measure will be administered at the baseline assessment, prior to each therapy session, and the one-month follow-up assessment. The potential scores range from 0-80, with a lower score indicating less symptoms of PTSD.	Baseline to 9 weeks (one month post study treatment)
Number of Subjects That Completed All 5 WET Sessions	Tracking feasibility through number of subjects that complete all written exposure therapy	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Administer PTSD Scale-5 (CAPS-5)	The CAPS-5 is structured interview that assesses the DSM-5 criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Additional items that are not included in the total score evaluate overall symptom duration, distress, impairment, dissociative symptoms, and global ratings by the interviewer. Scores range from 0-80, with lower scores indicating less PTSD severity.	Baseline to 9 weeks (one month post study treatment)
Patient Health Questionnaire-9 (PHQ)	The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms. It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders. Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores range from 0-27, with lower scores indicating less depression severity.	Baseline to 9 weeks (one month post study treatment)
Generalize Anxiety Disorder-7 (GAD)	The GAD-7will be used to assess generalized anxiety symptomology. This is a 7-item measure that asks participants to rate the frequency with which they have been bothered by anxiety symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores range from 0-21, with lower scores indicating less anxiety severity.	Baseline to 9 weeks (one month post study treatment)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Casey Straud, PsyD, University of Texas Health Science Center San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Brain stimulation
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: HSC20220158H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the conclusion of this study, participants who signed the consent to have their data placed in the STRONG STAR Repository will be maintained under the UTHSCSA IRB-approved Repository protocol. For participants who decline participation in the STRONG STAR Repository, at the conclusion of the study their data will be de-identified and the data maintained in the Repository without identifiers. The IRB approved STRONG STAR Repository is a large comprehensive database of information, biological specimens and neuroimages related to the identification, assessment, and treatment of posttraumatic stress disorder (PTSD), insomnia, pain, and related behavioral health conditions. No biospecimen data is being collected in this study.
• IPD Sharing Time Frame: Anticipated study duration is 24 months to obtaining, cleaning and analysis of the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No