Back to resultsTranscranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy
Primary Purpose
Post Traumatic Stress Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soterix 1x1 tDCS mini CT
Sham Soterix 1x1 tDCS Mini CT
Written Exposure Therapy (WET)
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Brain stimulation
Eligibility Criteria
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 or metallic objects in body other than dental appliances/fillings (e.g., cardiac pacemaker, cochlear implants, medical pump, metal plates, or shrapnel).
- Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by the bipolar and psychosis modules of the MINI)
- 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.
Sites / Locations
- The University of Texas Health Science Center at San AntonioRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
tDCS plus WET
Sham plus WET
Arm Description
Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)
Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)
Outcomes
Primary Outcome Measures
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.
Number of subjects that completed all 5 WET sessions
Tracking feasibility through number of subjects that complete all written exposure therapy
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05419999
First Posted
June 10, 2022
Last Updated
August 29, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT05419999
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Brain stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Early phase II, two-arm, single-blind pilot Research clinical trial
Masking
Participant
Masking Description
Subjects will be blinded to whether they receive actual tDCS or sham treatment
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS plus WET
Arm Type
Experimental
Arm Description
Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)
Arm Title
Sham plus WET
Arm Type
Sham Comparator
Arm Description
Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)
Intervention Type
Device
Intervention Name(s)
Soterix 1x1 tDCS mini CT
Other Intervention Name(s)
Transcranial Direct Current Stimulator
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Soterix 1x1 tDCS Mini CT
Other Intervention Name(s)
Sham Transcranial Direct Current Stimulator
Intervention Description
Sham setting is used on the Soterix transcranial electrical stimulator
Intervention Type
Behavioral
Intervention Name(s)
Written Exposure Therapy (WET)
Intervention Description
An exposure-based, behavioral psychotherapy for PTSD.
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder Checklist (PCL-5)
Description
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.
Time Frame
Baseline to 9 weeks (one month post study treatment)
Title
Number of subjects that completed all 5 WET sessions
Description
Tracking feasibility through number of subjects that complete all written exposure therapy
Time Frame
5 weeks
Title
Number of reported adverse events reported
Description
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.
Time Frame
Baseline to 9 weeks (one month post study treatment)
Secondary Outcome Measure Information:
Title
Clinician Administer PTSD Scale-5 (CAPS-5)
Description
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.
Time Frame
Baseline to 9 weeks (one month post study treatment)
Title
Patient Health Questionnaire-9 (PHQ)
Description
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.
Time Frame
Baseline to 9 weeks (one month post study treatment)
Title
Generalize Anxiety Disorder-7 (GAD)
Description
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.
Time Frame
Baseline to 9 weeks (one month post study treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Casey Straud, PsyD
Phone
210-562-6742
Email
straud@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Flores, BS
Phone
210-562-6726
Email
Floresa13@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Casey Straud, PsyD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey L Straud, PsyD
Phone
210-562-6742
Email
straud@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Amanda Flores, BS
Phone
210-562-6726
Email
floresa13@uthscsa.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
At the conclusion of this study, participants who signed the consent to have their data placed in the STRONG STAR Repository will be maintained under the UTHSCSA IRB-approved Repository protocol. For participants who decline participation in the STRONG STAR Repository, at the conclusion of the study their data will be de-identified and the data maintained in the Repository without identifiers. The IRB approved STRONG STAR Repository is a large comprehensive database of information, biological specimens and neuroimages related to the identification, assessment, and treatment of posttraumatic stress disorder (PTSD), insomnia, pain, and related behavioral health conditions. No biospecimen data is being collected in this study.
IPD Sharing Time Frame
Anticipated study duration is 24 months to obtaining, cleaning and analysis of the data.
Learn more about this trial
Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy
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