Post Traumatic Stress DisorderNCT05419999
Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy
A study testing Soterix 1x1 tDCS mini CT and Written Exposure Therapy (WET) in people with Post Traumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Soterix 1x1 tDCS mini CT and Written Exposure Therapy (WET)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 25 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
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
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).
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Soterix 1x1 tDCS mini CT, Sham Soterix 1x1 tDCS Mini CT, Written Exposure Therapy (WET)
- Keywords
- Brain stimulation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soterix 1x1 tDCS mini CTDevice
Also called Transcranial Direct Current Stimulator
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.
Sham Soterix 1x1 tDCS Mini CTOther
Also called Sham Transcranial Direct Current Stimulator
Sham setting is used on the Soterix transcranial electrical stimulator
Written Exposure Therapy (WET)Behavioural
An exposure-based, behavioral psychotherapy for PTSD.
| Study group | Role | What they receive |
|---|---|---|
| tDCS plus WET | Experimental | Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET) Receives: Device: Soterix 1x1 tDCS mini CT; Behavioral: Written Exposure Therapy (WET) |
| Sham plus WET | Sham comparator | Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET) Receives: Other: Sham Soterix 1x1 tDCS Mini CT; Behavioral: Written Exposure Therapy (WET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 5 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 9 weeks (one month post study treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start9 Jan 2023
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Early phase II, two-arm, partially double-blind pilot research clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casey Straud, The University of Texas Health Science Center at San Antonio
- Investigators
- Casey Straud, PsyD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419999
- Sponsor's protocol ID
- HSC20220158H
- Status last verified
- May 2025
- First submitted
- 10 Jun 2022
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05419999
- Acronym / sponsor ID
- HSC20220158H
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Posted 29 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Early phase II, two-arm, partially double-blind pilot research clinical trial
| Arm | Type | Receives |
|---|---|---|
| tDCS plus WET | Experimental | Device: Soterix 1x1 tDCS mini CT, Behavioral: Written Exposure Therapy (WET)Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET) |
| Sham plus WET | Sham comparator | Other: Sham Soterix 1x1 tDCS Mini CT, Behavioral: Written Exposure Therapy (WET)Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soterix 1x1 tDCS mini CTAlso: Transcranial Direct Current StimulatorDuring 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. | Device | tDCS plus WET |
| Sham Soterix 1x1 tDCS Mini CTAlso: Sham Transcranial Direct Current StimulatorSham setting is used on the Soterix transcranial electrical stimulator | Other | Sham plus WET |
| Written Exposure Therapy (WET)An exposure-based, behavioral psychotherapy for PTSD. | Behavioural | Sham plus WET, tDCS plus WET |
Primary outcome
Posttraumatic Stress Disorder Checklist (PCL-5)
Time frame: Baseline to 9 weeks (one month post study treatment)
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
Time frame: 5 weeks
Tracking feasibility through number of subjects that complete all written exposure therapy
3 secondary outcomes
Clinician Administer PTSD Scale-5 (CAPS-5)
Time frame: Baseline to 9 weeks (one month post study treatment)
Patient Health Questionnaire-9 (PHQ)
Time frame: Baseline to 9 weeks (one month post study treatment)
Generalize Anxiety Disorder-7 (GAD)
Time frame: Baseline to 9 weeks (one month post study treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Casey Straud, PsyD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soterix 1x1 tDCS mini CT and Written Exposure Therapy (WET) in people with Post Traumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Disorder Checklist (PCL-5) (time frame: Baseline to 9 weeks (one month post study treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.