Clinical trial NCT05419999: Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Brain stimulation
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Early phase II, two-arm, partially double-blind pilot research clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Posttraumatic Stress Disorder Checklist (PCL-5)
timeFrame: Baseline to 9 weeks (one month post study treatment)
measure: Number of Subjects That Completed All 5 WET Sessions
timeFrame: 5 weeks
Secondary outcomes:
measure: Clinician Administer PTSD Scale-5 (CAPS-5)
timeFrame: Baseline to 9 weeks (one month post study treatment)
measure: Patient Health Questionnaire-9 (PHQ)
timeFrame: Baseline to 9 weeks (one month post study treatment)
measure: Generalize Anxiety Disorder-7 (GAD)
timeFrame: Baseline to 9 weeks (one month post study treatment)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Casey Straud, PsyD
role: PRINCIPAL_INVESTIGATOR
References: