Chronic PainNCT07116109
Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Integrated Treatment for Pain and PTSD
A study testing Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE) in people with Chronic Pain and Post Traumatic Stress Disorder (PTSD), run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
The purpose of this study is to examine comparative effectiveness of two home-based telemedicine delivered interventions: transcranial Direct Current Stimulation (tDCS) combined with Massed Prolonged Exposure (Massed-PE) vs. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Pain, Post Traumatic Stress Disorder (PTSD)
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2025to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of musculoskeletal, chronic, non-cancer pain with a rating of ≥ 3 out of 10 on a 0-10 on the Defense and Veterans Pain Rating Scale (DVPRS) and a pain intensity and interference score of 1 standard deviation above PROMIS normative data (see Measures section below). Symptoms will be required to be of at least six months duration and verified diagnosis in their medical chart authorized by informed consent
- Diagnosis of PTSD assigned on the basis of the Clinician Administered PTSD Scale (CAPS-5) and PCL-5 ≥ 30
- willing to participate in study randomization, treatment assignment, and assessments.
Who cannot join
- Having a household member who is already enrolled in the study
- Active psychosis or dementia at screening
- Suicidal ideation with clear intent
- Current substance dependence
- current opioid medication for pain and/or current use of sodium channel blockers, calcium channel blockers, or N-Methyl-D-aspartate receptor antagonists, because these medications can block tDCS effects
- pregnancy and/or lactation
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- concurrent enrollment in another pain clinical trial
- tDCS or medical related contraindications such as open-injury TBI (penetrating injury), seizure disorder (independently of the type of TBI or condition causing the seizure disorder), pregnancy, implanted metal, claustrophobia
- having pain that is not chronic, presence of severe and frequent migraines, fibromyalgia, or pain caused by a primary condition such as cancer.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Charleston VA Healthcare System
Charleston, South Carolina, 29401-5799
Stephanie Hart, 843-577-5011, Stephanie.Hart4@va.gov
- Active, not recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Entirely Remote 2-Week Integrated Treatment for Pain and PTSD
The purpose of this study is to examine comparative effectiveness of two home-based telemedicine delivered interventions: transcranial Direct Current Stimulation (tDCS) combined with Massed Prolonged Exposure (Massed-PE) vs. Sham tDCS combined with Massed PE, focusing on pain and PTSD outcomes, to determine the comparative effectiveness of the two interventions on process outcomes of patient satisfaction, treatment attrition, and treatment compliance and to explore changes in blood biomarkers associated with stress and inflammatory processes related to pain and PTSD symptom improvements following treatment.
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Massed-Prolonged Exposure (PE), Sham Transcranial Direct Current Stimulation (tDCS)
- Keywords
- PTSD, transcranial Direct Current Stimulation (tDCS), Traumatic Brain Injury (TBI)
- Medical subject headings
- Chronic Pain, Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic
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
A constant current intensity of 2 Ma electrical current will be administered for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday)using the headgear M1-SO montage placement.
Massed-Prolonged Exposure (PE)Behavioural
PE will include a) psychoeducation about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 10), c) repeated, prolonged, imaginal exposure to traumatic memories (sessions 3 through 10). All sessions will be delivered via telehealth.
Sham Transcranial Direct Current Stimulation (tDCS)Device
Sham tDCS delivers an active stimulation of 2 Ma electrical current) for a few seconds to mimic the sensations of active tDCS
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE) | Experimental | Not described Receives: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Massed-Prolonged Exposure (PE) |
| Sham Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE) | Sham comparator | Not described Receives: Behavioral: Massed-Prolonged Exposure (PE); Device: Sham Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity as measured by the Defense and Veterans Pain Rating Scale (DVPRS)
The DVPRS is a validated 11-point numeric rating scale and is scored from 0(no pain at all) to 10(worst pain ever possible), higher scores indicate greater pain severity.
Measured: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months
Change in PTSD symptoms as assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
The CAPS-5 is a 30-item structured clinical interview used to assess the presence and severity of Posttraumatic Stress Disorder (PTSD) symptoms according to Diagnostic and Statistical Manual of Mental Disorders(DSM-5)diagnostic criteria. The scale includes 20 core PTSD symptom items rated on a 5-point scale (0-4) for both frequency and intensity. Each item receives a severity score ranging from 0 (absent) to 4 (extreme/incapacitating), for a total score range of 0 to 80. Higher scores indicate greater PTSD symptom severity.
Measured: Baseline, post treatment (after session 10) 3 months, 6 months
Secondary outcomes (7)
Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
This is a 3 item questionnaire and each is scored from 1 (no pain) to 5 (very severe) , maximum score of 15. Higher score indicates greater pain intensity
Measured: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months
Change in pain interference as assessed by the PROMIS Pain 8a Interference Scale
This is a 8 item questionnaire scored from 1 (not at all) to 5 (very much) , raw score range is 8-40, higher scores indicating greater pain interference.
Measured: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months
Change in symptoms of Post-Traumatic Stress Disorder (PTSD)as assessed by the PTSD Checklist-5 Civilian (PCL-5)
This is a 20 item questionnaire each scored from 0(not at all) to 4( extremely), for a total score range of 0-80 higher scores indicating worse outcome
Measured: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months
Change in Quality of life as assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
This is a 26-item measure categorized into four domains (i.e., physical health, psychological well- being, social relationships, and environment).Each item is rated on a 5-point Likert scale ranging from 1 (low perception) to 5 (high perception). Domain scores are calculated and transformed to a 0-100 scale, with higher scores indicating better perceived quality of life. Two additional items assess overall quality of life and general health.
Measured: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months
Change in anxiety as assessed by the Generalized Anxiety Disorder Scale 7 (GAD-7)
This is a 7 item questionnaire , each scored from 0( not at all) to 3(nearly every day) for a maximum score range of 0-21 higher scores indicating more anxiety
Measured: Baseline,post treatment (after session 10) 3 months, 6 months
Quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item self-report questionnaire. There are 7 component scores (subjective sleep quality, sleep latency, duration, efficiency, disturbances, medication use, daytime dysfunction) and each is scored from 0 (No difficulty or very good sleep) to 3 ( Severe difficulty) for a score range of 0-21 higher score indicating poor sleep
Measured: Baseline, post treatment (after session 10) 3 months, 6 months
Change in depression as assessed by the The Patient Health Questionnaire (PHQ-9)
This is a 9 item questionnaire and each is scored on a 4 point likert scale from 0(not at all) to 3(nearly every day) for a score range of 0-27 higher scores indicating worse outcome
Measured: Baseline, post treatment (after session 10) 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jul 2025
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Melba Hernandez-Tejada, PhD, DHA, The University of Texas Health Science Center, Houston
- Investigators
- Melba Hernandez-Tejada, PhD, DHA, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116109
- Sponsor's protocol ID
- HSC-MS-25-0436
- Status last verified
- Mar 2026
- First submitted
- 4 Aug 2025
- Last updated
- 3 Apr 2026
- 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Entirely Remote 2-Week Integrated Treatment for Pain and PTSD
- ClinicalTrials.gov ID
- NCT07116109
- Acronym / sponsor ID
- HSC-MS-25-0436
- Keywords
- PTSD, transcranial Direct Current Stimulation (tDCS), Traumatic Brain Injury (TBI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 11 Aug 2025 (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 examine comparative effectiveness of two home-based telemedicine delivered interventions: transcranial Direct Current Stimulation (tDCS) combined with Massed Prolonged Exposure (Massed-PE) vs. Sham tDCS combined with Massed PE, focusing on pain and PTSD outcomes, to determine the comparative effectiveness of the two interventions on process outcomes of patient satisfaction, treatment attrition, and treatment compliance and to explore changes in blood biomarkers associated with stress and inflammatory processes related to pain and PTSD symptom improvements following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE) | Experimental | Device: Transcranial Direct Current Stimulation (tDCS), Behavioral: Massed-Prolonged Exposure (PE) |
| Sham Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE) | Sham comparator | Behavioral: Massed-Prolonged Exposure (PE), Device: Sham Transcranial Direct Current Stimulation (tDCS) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of musculoskeletal, chronic, non-cancer pain with a rating of ≥ 3 out of 10 on a 0-10 on the Defense and Veterans Pain Rating Scale (DVPRS) and a pain intensity and interference score of 1 standard deviation above PROMIS normative data (see Measures section below). Symptoms will be required to be of at least six months duration and verified diagnosis in their medical chart authorized by informed consent
- Diagnosis of PTSD assigned on the basis of the Clinician Administered PTSD Scale (CAPS-5) and PCL-5 ≥ 30
- willing to participate in study randomization, treatment assignment, and assessments.
Key exclusion criteria (9 listed)
- Having a household member who is already enrolled in the study
- Active psychosis or dementia at screening
- Suicidal ideation with clear intent
- Current substance dependence
- current opioid medication for pain and/or current use of sodium channel blockers, calcium channel blockers, or N-Methyl-D-aspartate receptor antagonists, because these medications can block tDCS effects
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)A constant current intensity of 2 Ma electrical current will be administered for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday)using the headgear M1-SO montage placement. | Device | Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE) |
| Massed-Prolonged Exposure (PE)PE will include a) psychoeducation about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 10), c) repeated, prolonged, imaginal exposure to traumatic memories (sessions 3 through 10). All sessions will be delivered via telehealth. | Behavioural | Sham Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE), Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE) |
| Sham Transcranial Direct Current Stimulation (tDCS)Sham tDCS delivers an active stimulation of 2 Ma electrical current) for a few seconds to mimic the sensations of active tDCS | Device | Sham Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE) |
Primary outcome
Change in pain intensity as measured by the Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months
The DVPRS is a validated 11-point numeric rating scale and is scored from 0(no pain at all) to 10(worst pain ever possible), higher scores indicate greater pain severity.
Change in PTSD symptoms as assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
Time frame: Baseline, post treatment (after session 10) 3 months, 6 months
The CAPS-5 is a 30-item structured clinical interview used to assess the presence and severity of Posttraumatic Stress Disorder (PTSD) symptoms according to Diagnostic and Statistical Manual of Mental Disorders(DSM-5)diagnostic criteria. The scale includes 20 core PTSD symptom items rated on a 5-point scale (0-4) for both frequency and intensity. Each item receives a severity score ranging from 0 (absent) to 4 (extreme/incapacitating), for a total score range of 0 to 80. Higher scores indicate greater PTSD symptom severity.
7 secondary outcomes
Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
Time frame: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months
Change in pain interference as assessed by the PROMIS Pain 8a Interference Scale
Time frame: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months
Change in symptoms of Post-Traumatic Stress Disorder (PTSD)as assessed by the PTSD Checklist-5 Civilian (PCL-5)
Time frame: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months
Change in Quality of life as assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
Time frame: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months
Change in anxiety as assessed by the Generalized Anxiety Disorder Scale 7 (GAD-7)
Time frame: Baseline,post treatment (after session 10) 3 months, 6 months
Quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, post treatment (after session 10) 3 months, 6 months
Change in depression as assessed by the The Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, post treatment (after session 10) 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- 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.
Melba Hernandez-Tejada, PhD, DHA principal investigator
The University of Texas Health Science Center, Houston
2 sites 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 Massed-Prolonged Exposure (PE) in people with Chronic Pain and Post Traumatic Stress Disorder (PTSD), run by The University of Texas Health Science Center, Houston at 2 sites 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 9 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melba Hernandez-Tejada, PhD, DHA (713 4862729, Melba.A.HernandezTejada@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity as measured by the Defense and Veterans Pain Rating Scale (DVPRS) (time frame: Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months). 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 3 Apr 2026.