Home-based brain stimulation plus intensive prolonged exposure for chronic pain and PTSD
Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Entirely Remote 2-Week Integrated Treatment for Pain and PTSD
This trial will see if adding home-based transcranial direct current stimulation (tDCS) to an intensive, telemedicine-delivered prolonged exposure program helps people with chronic musculoskeletal pain and PTSD reduce symptoms and improve satisfaction compared with sham stimulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 2 sites (Charleston, South Carolina and 1 other locations) |
| Trial ID | NCT07116109 on ClinicalTrials.gov |
What this trial studies
Participants are randomized to receive either active tDCS plus massed prolonged exposure (Massed-PE) or sham tDCS plus Massed-PE, with both interventions delivered primarily at home via telemedicine. The primary clinical targets are chronic musculoskeletal pain (≥6 months duration, DVPRS ≥3 and elevated PROMIS scores) and PTSD (diagnosed by CAPS-5 with PCL-5 ≥30). The study also measures process outcomes such as patient satisfaction, treatment attrition, and compliance, and explores changes in blood biomarkers of stress and inflammation tied to symptom change. Treatments combine a behavioral exposure protocol with portable neuromodulation to test an integrated, technology-enhanced approach.
Who should consider this trial
Good fit: Adults with chronic non-cancer musculoskeletal pain for at least six months and a clinical diagnosis of PTSD (CAPS-5 and PCL-5 ≥30) who are willing to be randomized and complete telemedicine sessions are ideal candidates.
Not a fit: People with active psychosis, dementia, suicidal intent, current substance dependence, or those taking opioids or certain channel-blocking or NMDA antagonist medications are excluded and may not benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could offer a scalable home-based treatment that reduces both chronic pain and PTSD symptoms and improves treatment engagement.
How similar studies have performed: Previous research has shown modest benefits of tDCS for pain and strong evidence for prolonged exposure in PTSD, but combining home-based tDCS with massed PE is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Charleston, South Carolina and 1 other locations
- Charleston VA Healthcare System — Charleston, South Carolina, United States (Recruiting)
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Melba Hernandez-Tejada, PhD, DHA — The University of Texas Health Science Center, Houston
- Study coordinator: Melba Hernandez-Tejada, PhD, DHA
- Email: Melba.A.HernandezTejada@uth.tmc.edu
- Phone: 713 4862729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.