Neuromodulation + Prolonged Exposure Therapy for Chronic Pain and PTSD

This study is testing two home-based treatments for people experiencing both chronic pain and Post-Traumatic Stress Disorder (PTSD). Researchers are comparing Transcranial Direct Current Stimulation (tDCS) combined with Massed Prolonged Exposure (PE) therapy against a sham (inactive) tDCS combined with Massed PE. tDCS uses a mild electrical current to stimulate the brain, and PE is a type of therapy that helps you gradually face trauma-related memories and situations. The study aims to see how well these treatments reduce pain intensity and PTSD symptoms. You may be able to join if you are 21 or older, have ongoing musculoskeletal pain rated 3 or higher out of 10, and have PTSD. The study plans to enroll 146 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing two different treatment combinations. It plans to enroll 146 participants.
What's involved
You would receive 10 daily treatment sessions over two weeks (Monday to Friday). These sessions involve either active or sham tDCS and Massed Prolonged Exposure therapy.
Compensation
Not stated in the trial record.
Follow-up
Your pain and PTSD symptoms will be measured at the start, midpoint, and end of treatment, and then again at 3 and 6 months after treatment.

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NCT07116109

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

Recruiting
NAAges 21+InterventionalTreatment
The University of Texas Health Science Center, Houston
~146 participants
Updated 2026-04-03 on ClinicalTrials.gov
What's tested:Transcranial Direct Current Stimulation (tDCS)Massed-Prolonged Exposure (PE)Sham Transcranial Direct Current Stimulation (tDCS)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pain intensity as measured by the Defense and Veterans Pain Rating Scale (DVPRS)
Measured over Baseline, midpoint(before session 6), post treatment (after session 10) 3 months, 6 months
+1 more outcome measured
Chronic Pain
Post Traumatic Stress Disorder (PTSD)
2 sites across 2 states
South Carolina1
Texas1
  • Melba Hernandez-Tejada, PhD, DHA · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
  • 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

    The DVPRS is a validated 11-point numeric rating scale and is scored from 0(no pain at all) to 10(worst pain ever possible), higher scores indicate greater pain severity.

  • 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

    The CAPS-5 is a 30-item structured clinical interview used to assess the presence and severity of Posttraumatic Stress Disorder (PTSD) symptoms according to Diagnostic and Statistical Manual of Mental Disorders(DSM-5)diagnostic criteria. The scale includes 20 core PTSD symptom items rated on a 5-point scale (0-4) for both frequency and intensity. Each item receives a severity score ranging from 0 (absent) to 4 (extreme/incapacitating), for a total score range of 0 to 80. Higher scores indicate greater PTSD symptom severity.