Actively Recruiting
Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Integrated Treatment for Pain and PTSD
Led by The University of Texas Health Science Center, Houston · Updated on 2026-04-03
146
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Integrated Treatment for Pain and PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 years or older
- Presence of musculoskeletal chronic non-cancer pain with a rating of 3 or higher on the Defense and Veterans Pain Rating Scale
- Pain intensity and interference score at least 1 standard deviation above PROMIS norms
- Pain symptoms lasting at least six months with diagnosis verified in medical records
- Diagnosis of PTSD confirmed by Clinician Administered PTSD Scale (CAPS-5) and PCL-5 score of 30 or higher
- Willingness to participate in randomization, treatment, and assessments
You will not qualify if you...
- Having a household member already enrolled in the study
- Active psychosis or dementia at screening
- Suicidal ideation with clear intent
- Current substance dependence
- Current opioid medication use or use of sodium channel blockers, calcium channel blockers, or N-Methyl-D-aspartate receptor antagonists
- Pregnancy or breastfeeding
- Enrollment in another pain clinical trial
- Contraindications to tDCS or related medical conditions such as open-injury traumatic brain injury, seizure disorder, implanted metal, or claustrophobia
- Non-chronic pain conditions, severe frequent migraines, fibromyalgia, or pain caused by cancer
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Charleston VA Healthcare System
Charleston, South Carolina, United States, 29401-5799
Actively Recruiting
2
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Active, Not Recruiting
Research Team
M
Melba Hernandez-Tejada, PhD, DHA
CONTACT
S
Stephanie Hart
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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