RecruitingNot ApplicableNCT07116109

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

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

Sponsor

The University of Texas Health Science Center, Houston

Enrollment

146 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Post Traumatic Stress Disorder (PTSD)

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

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combined treatment approach for veterans and others who have both chronic pain and PTSD — two conditions that often occur together and make each other worse. It combines a mild brain stimulation technique (tDCS) with an evidence-based trauma therapy called Prolonged Exposure (PE). **You may be eligible if...** - You have chronic pain (rated at least 3 out of 10) that has lasted at least 6 months - You have been diagnosed with PTSD based on a formal evaluation - You are willing to be randomly assigned to a treatment group and complete all assessments **You may NOT be eligible if...** - You live in the same household as another study participant - You have active psychosis or dementia - You have current suicidal intent - You currently depend on substances (not including caffeine or tobacco) - You take certain medications that can interfere with brain stimulation (opioids, sodium/calcium channel blockers, NMDA antagonists) - You are pregnant or breastfeeding - You have a pacemaker, metal implants in the head, or a seizure disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETranscranial Direct Current Stimulation (tDCS)

A constant current intensity of 2 Ma electrical current will be administered for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday)using the headgear M1-SO montage placement.

BEHAVIORALMassed-Prolonged Exposure (PE)

PE will include a) psychoeducation about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 10), c) repeated, prolonged, imaginal exposure to traumatic memories (sessions 3 through 10). All sessions will be delivered via telehealth.

DEVICESham Transcranial Direct Current Stimulation (tDCS)

Sham tDCS delivers an active stimulation of 2 Ma electrical current) for a few seconds to mimic the sensations of active tDCS