Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Integrated Treatment for Pain and PTSD
1 other identifier
interventional
146
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Jul 2025
Longer than P75 for not_applicable chronic-pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2025
CompletedFirst Submitted
Initial submission to the registry
August 4, 2025
CompletedFirst Posted
Study publicly available on registry
August 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
March 27, 2026
March 1, 2026
3.6 years
August 4, 2025
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
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
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
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)
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)
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)
Baseline,post treatment (after session 10) 3 months, 6 months
- +2 more secondary outcomes
Study Arms (2)
Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)
EXPERIMENTALSham Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)
SHAM COMPARATORInterventions
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.
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 tDCS delivers an active stimulation of 2 Ma electrical current) for a few seconds to mimic the sensations of active tDCS
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Charleston VA Healthcare System
Charleston, South Carolina, 29401-5799, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melba Hernandez-Tejada, PhD, DHA
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 4, 2025
First Posted
August 11, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
January 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share