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

The University of Texas System (UT)

Status

Enrolling

Conditions

Post Traumatic Stress Disorder (PTSD)

Chronic Pain

Treatments

Device: Transcranial Direct Current Stimulation (tDCS)

Device: Sham Transcranial Direct Current Stimulation (tDCS)

Behavioral: Massed-Prolonged Exposure (PE)

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT07116109

HSC-MS-25-0436

Details and patient eligibility

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.

Enrollment

146 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.