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

NCT ID: NCT05419999

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2024-04-25

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).

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.

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

tDCS plus WET

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

Group Type: EXPERIMENTAL

Soterix 1x1 tDCS mini CT

Intervention Type: 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.

Written Exposure Therapy (WET)

Intervention Type: BEHAVIORAL

An exposure-based, behavioral psychotherapy for PTSD.

Sham plus WET

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

Group Type: SHAM_COMPARATOR

Sham Soterix 1x1 tDCS Mini CT

Intervention Type: OTHER

Sham setting is used on the Soterix transcranial electrical stimulator

Written Exposure Therapy (WET)

Intervention Type: BEHAVIORAL

An exposure-based, behavioral psychotherapy for PTSD.

Interventions

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.

Intervention Type: DEVICE

Sham Soterix 1x1 tDCS Mini CT

Sham setting is used on the Soterix transcranial electrical stimulator

Intervention Type: OTHER

Written Exposure Therapy (WET)

An exposure-based, behavioral psychotherapy for PTSD.

Intervention Type: BEHAVIORAL

Other Intervention Names

Transcranial Direct Current Stimulator; Sham Transcranial Direct Current Stimulator

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Casey Straud

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Casey Straud, PsyD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HSC20220158H

Identifier Type: -

Identifier Source: org_study_id