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Completed

NCT Number: NCT05419999

Transcranial Direct Current Stimulation (tDCS) in Human Subjects With 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).

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Transcranial Direct Current Stimulator

Sham Soterix 1x1 tDCS Mini CT

Other

Sham setting is used on the Soterix transcranial electrical stimulator

Other names: Sham Transcranial Direct Current Stimulator

Written Exposure Therapy (WET)

Behavioral

An exposure-based, behavioral psychotherapy for PTSD.

Primary outcomes

  1. Posttraumatic Stress Disorder Checklist (PCL-5)

    Time frame: Baseline to 9 weeks (one month post study treatment)

    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.

  2. Number of Subjects That Completed All 5 WET Sessions

    Time frame: 5 weeks

    Tracking feasibility through number of subjects that complete all written exposure therapy

Secondary outcomes

  1. Clinician Administer PTSD Scale-5 (CAPS-5)

    Time frame: Baseline to 9 weeks (one month post study treatment)

    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.

  2. Patient Health Questionnaire-9 (PHQ)

    Time frame: Baseline to 9 weeks (one month post study treatment)

    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.

  3. Generalize Anxiety Disorder-7 (GAD)

    Time frame: Baseline to 9 weeks (one month post study treatment)

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2022
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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