Recruiting

tDCS & Massed-PE

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07116109

Conditions

Chronic Pain

Post Traumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Transcranial Direct Current Stimulation (tDCS)

Massed-Prolonged Exposure (PE)

Sham Transcranial Direct Current Stimulation (tDCS)

Study Details

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.

Conditions

Chronic Pain

Post Traumatic Stress Disorder (PTSD)

Study ID

NCT07116109

Start date

Jul 1, 2025

Status verified date

Mar, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jan 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

146 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)

sham comparator: Sham Transcranial Direct Current Stimulation (tDCS) and Massed-Prolonged Exposure (PE)

Interventions

Transcranial 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.

Massed-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.

Sham 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

Primary outcome measure

  • Change in pain intensity as measured by the Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: 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) [ Time Frame: Baseline, post treatment (after session 10) 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Melba Hernandez-Tejada, PhD, DHA

713 4862729Melba.A.HernandezTejada@uth.tmc.edu

Stephanie Hart

843-577-5011 x205103zeigls@musc.edu

Locations

Charleston VA Healthcare System

Recruiting

Charleston, South Carolina, United States, 29401-5799

Contacts

Stephanie Hart

843-577-5011Stephanie.Hart4@va.gov

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Keywords

  • PTSD
  • transcranial Direct Current Stimulation (tDCS)
  • Traumatic Brain Injury (TBI)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-04-03.