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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07116109
Status
Recruiting
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Conditions

  • Chronic Pain
  • Post Traumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Direct Current Stimulation (tDCS) — DEVICE
    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) — BEHAVIORAL
    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) — DEVICE
    Sham tDCS delivers an active stimulation of 2 Ma electrical current) for a few seconds to mimic the sensations of active tDCS

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Mar 2026
Primary completion
Jan 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Charleston VA Healthcare SystemCharlestonSouth Carolina29401-5799
Stephanie Hart
[email protected]
843-577-5011
The University of Texas Health Science Center at HoustonHoustonTexas77030-

Find similar trials in Charleston, SC

By research site
Charleston VA Healthcare System· Charleston, SCThe University of Texas Health Science Center at Houston· Houston, TX

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