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

The University of Texas System (UT)

Status: Completed

Conditions: Post Traumatic Stress Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05419999

HSC20220158H

Details and patient eligibility

About

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).

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

tDCS plus WET

Experimental group

Description:

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

Treatment:

Behavioral: Written Exposure Therapy (WET)

Device: Soterix 1x1 tDCS mini CT

Sham plus WET

Sham Comparator group

Description:

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

Treatment:

Behavioral: Written Exposure Therapy (WET)

Other: Sham Soterix 1x1 tDCS Mini CT