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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Device: Soterix 1x1 tDCS mini CT
* Other: Sham Soterix 1x1 tDCS Mini CT
* Behavioral: Written Exposure Therapy (WET)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Early phase II, two-arm, single-blind pilot Research clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS plus WET<br>Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET) | Device: Soterix 1x1 tDCS mini CT<br>* 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.<br>* Other names: Transcranial Direct Current Stimulator;Behavioral: Written Exposure Therapy (WET)<br>* An exposure-based, behavioral psychotherapy for PTSD.<br>|
| Sham Comparator: Sham plus WET<br>Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET) | Other: Sham Soterix 1x1 tDCS Mini CT<br>* Sham setting is used on the Soterix transcranial electrical stimulator<br>* Other names: Sham Transcranial Direct Current Stimulator;Behavioral: Written Exposure Therapy (WET)<br>* An exposure-based, behavioral psychotherapy for PTSD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder Checklist (PCL-5) | 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. | Baseline to 9 weeks (one month post study treatment) | 
| Number of subjects that completed all 5 WET sessions | Tracking feasibility through number of subjects that complete all written exposure therapy | 5 weeks | 
| Number of reported adverse events reported | Participants are asked, Have you experienced any changes for the worse since your last visit? All reported events are documented by the research team member. Participants also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else. AEs will be reviewed and adjudicated with the study team during weekly meetings to ensure reliable coding and participant safety. | Baseline to 9 weeks (one month post study treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administer PTSD Scale-5 (CAPS-5) | 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. | Baseline to 9 weeks (one month post study treatment) | 
| Patient Health Questionnaire-9 (PHQ) | 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. | Baseline to 9 weeks (one month post study treatment) | 
| Generalize Anxiety Disorder-7 (GAD) | 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. | Baseline to 9 weeks (one month post study treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain stimulation