Posttraumatic Stress DisorderNCT04327362
TDCS-Augmented Prolonged Exposure Therapy
A study testing Transcranial Direct Current Stimulation (tDCS) and Prolonged Exposure Therapy in people with Posttraumatic Stress Disorder and PTSD, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of a brain stimulation technique known as transcranial direct current stimulation, or tDCS, on the benefits of Prolonged Exposure therapy, or PE, which is an effective treatment for posttraumatic stress disorder, or PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, PTSD, Anxiety
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS) and Prolonged Exposure Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65.
- Fluent in English.
- Diagnosis of chronic PTSD based on MINI for DSM-5 (> 3 mo. post-trauma)
- For Veterans recruited at the Ralph H. Johnson VA only: eligible to receive PE in the PCT clinic.
Who cannot join
- Currently receiving psychotherapy for another anxiety- or stress-related condition.
- Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment
- Medical condition that would contraindicate participation in treatment or assessment activities (e.g., severe cardiovascular problems).
- Pregnancy
- Current severe major depressive disorder
- Current, or history of bipolar disorder
Show all 12Show fewer
- Current, or history of psychotic symptoms
- Serious suicidal risk
- Active neurological conditions, e.g., seizures, stroke, loss of consciousness or concussion
- Contraindications for tDCS:
- Metal in the head.
- Implanted brain medical devices.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Crime Victim's Research & Treatment Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: TDCS-Augmented Prolonged Exposure Therapy for PTSD: a Multiple Baseline Within-Subject Clinical Trial
The purpose of this study is to determine the effects of a brain stimulation technique known as transcranial direct current stimulation, or tDCS, on the benefits of Prolonged Exposure therapy, or PE, which is an effective treatment for posttraumatic stress disorder, or PTSD. tDCS has been demonstrated to be safe and effective for influencing brain activity by passing a weak electrical current through the scalp. In this study, tDCS is provided in addition to PE treatment, through the National Crime Victim's Research and Treatment Center at MUSC, or the PTSD Clinical Team Clinic within the Ralph H. Johnson VA Medical Center.
Read the detailed description
This project implements a multiple baseline within-subject clinical trial design aiming to test whether tDCS targeting excitation of the medial prefrontal cortex (mPFC) can enhance a standard course of PE in a sample of adult civilians and Veterans (ages 18-65) who meet full DSM-5 criteria for chronic PTSD (i.e., > 3 months post-trauma; N = 20). All participants will receive a total of ten 60-min. sessions of manualized PE, preceded by 20 min. of either active or sham HD-tDCS. The stepped-wedge multiple baseline design features tDCS as a 2-level within-subject factor (Sham tDCS+PE vs. Active tDCS+PE), and between-subject comparisons based on stratified random assignment to cross-over from sham to active tDCS just prior to sessions 4 through 8. Strata will be defined by dichotomous classifications of possible confounds, including baseline severity (moderate vs. severe), psychotropic medication status (no vs. yes), and sex (female vs. male). The sample will consist of treatment-seeking civilian and Veteran participants referred by either of two of our consortium sites, including the National Crime Victim's Research and Treatment Center (NCVC) at MUSC, or the PTSD Clinical Team (PCT) at the Ralph H. Johnson VAMC, as well as community participants who respond to study advertisements.
- Conditions
- Posttraumatic Stress Disorder, PTSD, Anxiety, Depression
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Prolonged Exposure Therapy
- Keywords
- Non-invasive brain stimulation, Transcranial direct current stimulation, Exposure therapy, Prolonged Exposure, Civilians, Veterans, Trauma, Posttraumatic stress disorder, PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Also called Soterix Medical 1 x 1 Transcranial Electrical Stimulator (tES)
Participants will receive 20 min. of either sham or active tDCS prior to PE sessions using a 1 x 1 tDCS device with a ring electrode configuration that allows relatively excitatory and focal stimulation of the dorsomedial prefrontal cortex (dmPFC). Electrodes consist of sponges in a silicone rubber holder with a metal mesh conductor saturated with normal saline. A center anode (2.5 cm diameter) and a ring-shaped cathode (diameter inner/outer: 9.2/11.50 cm) will be centered over the dmPFC, with the anode placed the midline at 15% of the Fz to FPz distance. Active stimulation will commence with a 15 sec. ramping up period to target current (1.5 mA), followed by constant current for 20 min., and a 15 sec. ramping down period. For all sham sessions, stimulation will be immediately ramped down over a 15 sec. period following the initial ramping up period, and subsequently ramped up over 15 sec. prior to the final ramping down period.
Prolonged Exposure TherapyBehavioural
Also called PE, CBT, Trauma-focused therapy
All participants will receive 10 weekly sessions of standard Prolonged Exposure Therapy, or PE, which is a gold standard trauma-focused cognitive behavioral treatment for PTSD. The first sessions (1-2) predominately consist of psychoeducation about PTSD and the rationale for treatment, whereas subsequent sessions (3-10) consist of imaginal and in vivo exposure, involving repeated, prolonged, systematic, and deliberate practice approaching trauma reminders, as well as cognitive and emotional processing reactions to an index trauma memory.
| Study group | Role | What they receive |
|---|---|---|
| Cluster 1: Sham to active tDCS crossover at PE Session 4. | Experimental | Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-3, and 20 min. of active tDCS prior to PE sessions 4-10. Receives: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Prolonged Exposure Therapy |
| Cluster 2: Sham to active tDCS crossover at PE Session 5. | Active comparator | Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-4, and 20 min. of active tDCS prior to PE sessions 5-10. Receives: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Prolonged Exposure Therapy |
| Cluster 3: Sham to active tDCS crossover at PE Session 6 | Active comparator | Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-5, and 20 min. of active tDCS prior to PE sessions 6-10. Receives: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Prolonged Exposure Therapy |
| Cluster 4: Sham to active tDCS crossover at PE Session 7. | Active comparator | Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-6, and 20 min. of active tDCS prior to PE sessions 7-10. Receives: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Prolonged Exposure Therapy |
| Cluster 5: Sham to active tDCS crossover at PE Session 8. | Active comparator | Participants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-7, and 20 min. of active tDCS prior to PE sessions 8-10. Receives: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Prolonged Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician-Rated PTSD Symptom Severity
Clinician-administered PTSD Symptom Scale Interview for DSM-5 (PSSI-5).
Total scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Measured: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
Change in Self-Reported PTSD Symptom Severity
Self-report scores on the PTSD Symptom Checklist for DSM-5 (PCL-5)
Total scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Measured: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
Change in Self-Reported Post-traumatic Cognitions
Self-report scores on the Post-traumatic Cognitions Inventory (PTCI-9)
Total scores range from 9 to 63, with high scores indicating greater endorsement of common and problematic trauma-related beliefs.
Measured: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
Change in Depression Symptoms
Self-report scores on the Beck Depression Inventory, 2nd Edition (BDI-II)
Total scores range from 0 to 63, with higher scores indicating greater severity of depression symptoms.
Measured: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
Change in Anxiety Symptoms
Self-report scores on the Beck Anxiety Inventory (BAI)
Total scores range from 0 to 63, with higher scores indicating greater severity of anxiety symptoms.
Measured: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
Secondary outcomes (4)
Within- and Between-Session Change in Trauma-Related Emotional Distress
Self-reported in-session Subjective Units of Distress Scale (SUDS)
Peak distress among repeated ratings obtained during therapy sessions from 0 = "no distress" to 100 = "extreme distress". Ratings will be obtained up to 13 times at each weekly Prolonged Exposure therapy session, for 10 weeks.
Measured: During weekly therapy sessions 1-10, for 10 weeks from baseline.
Within- and Between-Session Change in Heart Rate
Continuously recorded in-session heart rate
Heart rate will be continuously recorded during each weekly Prolonged Exposure therapy session, for 10 weeks.
Measured: During weekly therapy sessions 1-10, for 10 weeks from baseline.
Within- and Between-Session Change in Physiological Activation
Continuously recorded in-session skin conductance levels
Skin conductance levels will be continuously monitored during each weekly Prolonged Exposure therapy session, for 10 weeks.
Measured: During weekly therapy sessions 1-10, for 10 weeks from baseline.
Between-Session Change in Trauma Memory Engagement and Emotional Processing
Therapist-report scores on the Prolonged Exposure Therapist Questionnaire
Total scores range from 0 to 35, with higher scores indicating greater retrieval, processing, and meaning making during imaginal revisiting of the index trauma memory.
Measured: During weekly therapy sessions 1-10, for 10 weeks from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Oct 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Why it stopped: Study withdrawn due to delay in recruitment due to COVID-19; the PI also moved to a new institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Participants will be randomly assigned following stratification by baseline severity of PTSD symptoms, medication status, and sex to one of five clusters defined by the point of cross-over from sham to active tDCS administered just prior to PE therapy sessions, with the earliest cross-over occurring at session 4, and the latest at session 8.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam R. Cobb, Ph.D., Principal investigator, Medical University of South Carolina & Ralph H. Johnson VAMC ConsortiumLisa M. McTeague, Ph.D., Principal investigator, Medical University of South Carolina & Ralph H. Johnson VAMC ConsortiumBethany C. Wangelin, Ph.D., Principal investigator, Medical University of South Carolina & Ralph H. Johnson VAMC Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327362
- Sponsor's protocol ID
- 00093774
- Status last verified
- Oct 2024
- First submitted
- 25 Mar 2020
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TDCS-Augmented Prolonged Exposure Therapy for PTSD: a Multiple Baseline Within-Subject Clinical Trial
- ClinicalTrials.gov ID
- NCT04327362
- Acronym / sponsor ID
- 00093774
- Conditions
- Posttraumatic Stress Disorder, PTSD, Anxiety, Depression
- Keywords
- Non-invasive brain stimulation, Transcranial direct current stimulation, Exposure therapy, Prolonged Exposure, Civilians, Veterans, Trauma, Posttraumatic stress disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to delay in recruitment due to COVID-19; the PI also moved to a new institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of a brain stimulation technique known as transcranial direct current stimulation, or tDCS, on the benefits of Prolonged Exposure therapy, or PE, which is an effective treatment for posttraumatic stress disorder, or PTSD. tDCS has been demonstrated to be safe and effective for influencing brain activity by passing a weak electrical current through the scalp. In this study, tDCS is provided in addition to PE treatment, through the National Crime Victim's Research and Treatment Center at MUSC, or the PTSD Clinical Team Clinic within the Ralph H. Johnson VA Medical Center.
Detailed description
This project implements a multiple baseline within-subject clinical trial design aiming to test whether tDCS targeting excitation of the medial prefrontal cortex (mPFC) can enhance a standard course of PE in a sample of adult civilians and Veterans (ages 18-65) who meet full DSM-5 criteria for chronic PTSD (i.e., > 3 months post-trauma; N = 20). All participants will receive a total of ten 60-min. sessions of manualized PE, preceded by 20 min. of either active or sham HD-tDCS. The stepped-wedge multiple baseline design features tDCS as a 2-level within-subject factor (Sham tDCS+PE vs. Active tDCS+PE), and between-subject comparisons based on stratified random assignment to cross-over from sham to active tDCS just prior to sessions 4 through 8. Strata will be defined by dichotomous classifications of possible confounds, including baseline severity (moderate vs. severe), psychotropic medication status (no vs. yes), and sex (female vs. male). The sample will consist of treatment-seeking civilian and Veteran participants referred by either of two of our consortium sites, including the National Crime Victim's Research and Treatment Center (NCVC) at MUSC, or the PTSD Clinical Team (PCT) at the Ralph H. Johnson VAMC, as well as community participants who respond to study advertisements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Participants will be randomly assigned following stratification by baseline severity of PTSD symptoms, medication status, and sex to one of five clusters defined by the point of cross-over from sham to active tDCS administered just prior to PE therapy sessions, with the earliest cross-over occurring at session 4, and the latest at session 8.
| Arm | Type | Receives |
|---|---|---|
| Cluster 1: Sham to active tDCS crossover at PE Session 4. | Experimental | Device: Transcranial Direct Current Stimulation (tDCS), Behavioral: Prolonged Exposure TherapyParticipants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-3, and 20 min. of active tDCS prior to PE sessions 4-10. |
| Cluster 2: Sham to active tDCS crossover at PE Session 5. | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS), Behavioral: Prolonged Exposure TherapyParticipants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-4, and 20 min. of active tDCS prior to PE sessions 5-10. |
| Cluster 3: Sham to active tDCS crossover at PE Session 6 | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS), Behavioral: Prolonged Exposure TherapyParticipants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-5, and 20 min. of active tDCS prior to PE sessions 6-10. |
| Cluster 4: Sham to active tDCS crossover at PE Session 7. | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS), Behavioral: Prolonged Exposure TherapyParticipants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-6, and 20 min. of active tDCS prior to PE sessions 7-10. |
| Cluster 5: Sham to active tDCS crossover at PE Session 8. | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS), Behavioral: Prolonged Exposure TherapyParticipants in this cluster will receive 20 min. of sham tDCS prior to the PE sessions 1-7, and 20 min. of active tDCS prior to PE sessions 8-10. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65.
- Fluent in English.
- Diagnosis of chronic PTSD based on MINI for DSM-5 (> 3 mo. post-trauma)
- For Veterans recruited at the Ralph H. Johnson VA only: eligible to receive PE in the PCT clinic.
Key exclusion criteria (12 listed)
- Currently receiving psychotherapy for another anxiety- or stress-related condition.
- Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment
- Medical condition that would contraindicate participation in treatment or assessment activities (e.g., severe cardiovascular problems).
- Pregnancy
- Current severe major depressive disorder
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: Soterix Medical 1 x 1 Transcranial Electrical Stimulator (tES)Participants will receive 20 min. of either sham or active tDCS prior to PE sessions using a 1 x 1 tDCS device with a ring electrode configuration that allows relatively excitatory and focal stimulation of the dorsomedial prefrontal cortex (dmPFC). Electrodes consist of sponges in a silicone rubber holder with a metal mesh conductor saturated with normal saline. A center anode (2.5 cm diameter) and a ring-shaped cathode (diameter inner/outer: 9.2/11.50 cm) will be centered over the dmPFC, with the anode placed the midline at 15% of the Fz to FPz distance. Active stimulation will commence with a 15 sec. ramping up period to target current (1.5 mA), followed by constant current for 20 min., and a 15 sec. ramping down period. For all sham sessions, stimulation will be immediately ramped down over a 15 sec. period following the initial ramping up period, and subsequently ramped up over 15 sec. prior to the final ramping down period. | Device | Cluster 1: Sham to active tDCS crossover at PE Session 4., Cluster 2: Sham to active tDCS crossover at PE Session 5., Cluster 3: Sham to active tDCS crossover at PE Session 6, Cluster 4: Sham to active tDCS crossover at PE Session 7., Cluster 5: Sham to active tDCS crossover at PE Session 8. |
| Prolonged Exposure TherapyAlso: PE, CBT, Trauma-focused therapyAll participants will receive 10 weekly sessions of standard Prolonged Exposure Therapy, or PE, which is a gold standard trauma-focused cognitive behavioral treatment for PTSD. The first sessions (1-2) predominately consist of psychoeducation about PTSD and the rationale for treatment, whereas subsequent sessions (3-10) consist of imaginal and in vivo exposure, involving repeated, prolonged, systematic, and deliberate practice approaching trauma reminders, as well as cognitive and emotional processing reactions to an index trauma memory. | Behavioural | Cluster 1: Sham to active tDCS crossover at PE Session 4., Cluster 2: Sham to active tDCS crossover at PE Session 5., Cluster 3: Sham to active tDCS crossover at PE Session 6, Cluster 4: Sham to active tDCS crossover at PE Session 7., Cluster 5: Sham to active tDCS crossover at PE Session 8. |
Primary outcome
Change in Clinician-Rated PTSD Symptom Severity
Time frame: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
Clinician-administered PTSD Symptom Scale Interview for DSM-5 (PSSI-5). Total scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Change in Self-Reported PTSD Symptom Severity
Time frame: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
Self-report scores on the PTSD Symptom Checklist for DSM-5 (PCL-5) Total scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Change in Self-Reported Post-traumatic Cognitions
Time frame: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
Self-report scores on the Post-traumatic Cognitions Inventory (PTCI-9) Total scores range from 9 to 63, with high scores indicating greater endorsement of common and problematic trauma-related beliefs.
Change in Depression Symptoms
Time frame: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
Self-report scores on the Beck Depression Inventory, 2nd Edition (BDI-II) Total scores range from 0 to 63, with higher scores indicating greater severity of depression symptoms.
Change in Anxiety Symptoms
Time frame: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)
Self-report scores on the Beck Anxiety Inventory (BAI) Total scores range from 0 to 63, with higher scores indicating greater severity of anxiety symptoms.
4 secondary outcomes
Within- and Between-Session Change in Trauma-Related Emotional Distress
Time frame: During weekly therapy sessions 1-10, for 10 weeks from baseline.
Within- and Between-Session Change in Heart Rate
Time frame: During weekly therapy sessions 1-10, for 10 weeks from baseline.
Within- and Between-Session Change in Physiological Activation
Time frame: During weekly therapy sessions 1-10, for 10 weeks from baseline.
Between-Session Change in Trauma Memory Engagement and Emotional Processing
Time frame: During weekly therapy sessions 1-10, for 10 weeks from baseline.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Adam R. Cobb, Ph.D. principal investigator
Medical University of South Carolina & Ralph H. Johnson VAMC Consortium
Lisa M. McTeague, Ph.D. principal investigator
Medical University of South Carolina & Ralph H. Johnson VAMC Consortium
Bethany C. Wangelin, Ph.D. principal investigator
Medical University of South Carolina & Ralph H. Johnson VAMC Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) and Prolonged Exposure Therapy in people with Posttraumatic Stress Disorder and PTSD, run by Medical University of South Carolina 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 4 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: withdrawn, as of the sponsor's last update on 24 Oct 2024. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Clinician-Rated PTSD Symptom Severity (time frame: Pre-treatment (baseline), post-treatment (12 weeks post-baseline), and 1-month follow-up (16 weeks post-baseline)). The study lists 5 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 24 Oct 2024.