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Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Integrated Treatment for Pain and PTSD
NCT07116109 · The University of Texas Health Science Center, Houston
In plain English
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Official title
Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Entirely Remote 2-Week Integrated Treatment for Pain and PTSD
About this study
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 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.
Study design
Enrollment target: 146 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-07-01
Estimated completion: 2029-06-30
Last updated: 2026-04-03
Interventions
Device: Transcranial Direct Current Stimulation (tDCS)Behavioral: Massed-Prolonged Exposure (PE)Device: Sham Transcranial Direct Current Stimulation (tDCS)
Primary outcomes
- • Change in pain intensity as measured by the Defense and Veterans Pain Rating Scale (DVPRS) (Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months)
- • Change in PTSD symptoms as assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5) (Baseline, post treatment (after session 10) 3 months, 6 months)
Sponsor
The University of Texas Health Science Center, Houston · other
With: United States Department of Defense
Contacts & investigators
ContactMelba Hernandez-Tejada, PhD, DHA · contact · Melba.A.HernandezTejada@uth.tmc.edu · 713 4862729
ContactStephanie Hart · contact · zeigls@musc.edu · 843-577-5011 x205103
InvestigatorMelba Hernandez-Tejada, PhD, DHA · principal_investigator, The University of Texas Health Science Center, Houston
All locations (2)
Charleston VA Healthcare SystemRecruiting
Charleston, South Carolina, United States
The University of Texas Health Science Center at HoustonActive Not Recruiting
Houston, Texas, United States