Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT07116109

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

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here