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

The University of Texas System (UT) logo

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

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

Trial contacts and locations

1

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Central trial contact

Amanda Flores, BS; Casey Straud, PsyD

Data sourced from clinicaltrials.gov

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