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

NCT05419999 | Completed Results DMC FDA Device

• 1 other identifier: HSC20220158H
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Post Traumatic Stress Disorder

Keywords

Brain stimulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Clinician Administer PTSD Scale-5 (CAPS-5)

  Baseline to 9 weeks (one month post study treatment)

• Patient Health Questionnaire-9 (PHQ)

  Baseline to 9 weeks (one month post study treatment)

• Generalize Anxiety Disorder-7 (GAD)

  Baseline to 9 weeks (one month post study treatment)

Study Arms (2)

tDCS plus WET

EXPERIMENTAL

Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)

Device: Soterix 1x1 tDCS mini CT; Behavioral: Written Exposure Therapy (WET)

Sham plus WET

SHAM COMPARATOR

Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)

Other: Sham Soterix 1x1 tDCS Mini CT; Behavioral: Written Exposure Therapy (WET)

Interventions

Soterix 1x1 tDCS mini CT DEVICE

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.

Also known as: Transcranial Direct Current Stimulator

tDCS plus WET

Sham Soterix 1x1 tDCS Mini CT OTHER

Sham setting is used on the Soterix transcranial electrical stimulator

Also known as: Sham Transcranial Direct Current Stimulator

Sham plus WET

Written Exposure Therapy (WET) BEHAVIORAL

An exposure-based, behavioral psychotherapy for PTSD.

Sham plus WET; tDCS plus WET

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Casey Straud
• Organization: University of Texas Health Science Center at San Antonio

straud@uthscsa.edu

210-562-6700

Study Officials

• Casey Straud, PsyD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to whether they receive actual tDCS or sham treatment. All study team members will also be blinded to randomization, with the exception of the study team coordinator who will allocate device codes. This will allow for the blind to be broken in case of an emergency or serious adverse event.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Early phase II, two-arm, partially double-blind pilot research clinical trial

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: January 9, 2023
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Anticipated study duration is 24 months to obtaining, cleaning and analysis of the data.

Locations

US (1)