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Trials / Recruiting

RecruitingNCT07411859

Reboot Pain (tDCS)

Reboot Pain: Integrating Neuromodulation Into Clinical Care for Military and Veterans With Chronic Pain

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Emory University · Academic / Other
Sex
All
Age
18 Years – 89 Years
Healthy volunteers
Not accepted

Summary

This study will examine the effectiveness of tDCS (Transcranial Direct Current Stimulation) in reducing chronic pain when used with Emory Healthcare Veterans Program (EHVP)-ABHP (Accelerated Behavioral Health Program) participants as measured by the Pain, Enjoyment of Life and General Activity Scale (PEG).

Detailed description

This study protocol will test whether a non-drug brain stimulation method called Transcranial Direct Current Stimulation (tDCS) can help reduce chronic pain in military service members and veterans who are receiving mental health treatment through the Accelerated Behavioral Health Program (ABHP) at the Emory Healthcare Veterans Program (EHVP). The goal is to see if combining tDCS treatment with standard therapy will improve pain and overall well-being. The study population will include adult service members and veterans aged 18-89 who are experiencing chronic pain and enrolled in the Accelerated Behavioral Health Program (ABHP) for mental health care. The study will not include minors, prisoners, non-English speakers, or pregnant individuals, as well as those with certain medical contraindications. Participants will receive short (\~20 minute), daily tDCS treatment sessions for two weeks. tDCS is a non-invasive method delivering a weak electrical current to specific areas of the brain to help reduce pain signals. Participants will complete brief daily pain surveys, questionnaires, and standard clinical interviews. The tDCS sessions will either take place in person at Emory's Executive Park Clinic or virtually with assistance as needed. Participants will receive active tDCS treatment for two weeks and standard of care follow-up assessments at the 3, 6, and 12 month marks after treatment. Participants will be recruited from those patients already entering or a part of the Emory Healthcare Veterans Program (EHVP) in Atlanta, Georgia. The total enrollment for this study is up to 100 participants over the course of two years. It is expected that some individuals may not qualify after screening or will withdraw early. No specimens or biological samples will be stored for future research use. Data collected in the study will be de-identified and only used for this protocol. Participants will review and sign an electronic consent form using a secure online system before active participation in the study. The consent form ensures participants fully understand the study, and they can withdraw at any time without penalty.

Conditions

Interventions

TypeNameDescription
DEVICETranscranial Direct Current StimulationtDCS is a painless brain stimulation treatment that uses direct electrical currents (at a constant, low intensity level) to stimulate specific parts of the brain and help modulate neuronal activity. Participants will receive a series of tDCS treatments during the Accelerated Brain Health Program (ABHP) coupled with self-report of pain severity and interference tDCS has been used to improve cognitive functions and pain management. Starting Day 1 of EHVP-IOP, tDCS will be administered with a constant current intensity of 2 mA for 20 min per session for up to 10 sessions over 2 weeks

Timeline

Start date
2026-02-16
Primary completion
2027-05-01
Completion
2027-05-01
First posted
2026-02-17
Last updated
2026-04-14

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07411859. Inclusion in this directory is not an endorsement.