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Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Entirely Remote 2-Week Integrated Treatment for Pain and PTSD

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
United States
South Carolina
Charleston VA Healthcare System
RECRUITING
Charleston
Texas
The University of Texas Health Science Center at Houston
ACTIVE_NOT_RECRUITING
Houston
Contact Information
Primary
Melba Hernandez-Tejada, PhD, DHA
Melba.A.HernandezTejada@uth.tmc.edu
713 4862729
Backup
Stephanie Hart
zeigls@musc.edu
843-577-5011 x205103
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 146
Treatments
Experimental: Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)
Sham_comparator: Sham Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)
Sponsors
Collaborators: United States Department of Defense
Leads: The University of Texas Health Science Center, Houston

This content was sourced from clinicaltrials.gov