Home-based brain stimulation plus intensive prolonged exposure for chronic pain and PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.