NCT07116109 Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Integrated Treatment for Pain and PTSD
| NCT ID | NCT07116109 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2029-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 146 participants in total. It began in 2025-07-01 with a primary completion date of 2029-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Melba Hernandez-Tejada, PhD, DHA
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT07116109 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07116109 currently recruiting?
Yes, NCT07116109 is actively recruiting participants. Contact the research team at Melba.A.HernandezTejada@uth.tmc.edu for enrollment information.
Where is the NCT07116109 trial being conducted?
This trial is being conducted at Charleston, United States, Houston, United States.
Who is sponsoring the NCT07116109 clinical trial?
NCT07116109 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Melba Hernandez-Tejada, PhD, DHA at The University of Texas Health Science Center, Houston. The trial plans to enroll 146 participants.
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