The Emory Clinic
Atlanta, Georgia, 30308, United States
Location status: Recruiting
NCT Number: NCT07411859
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).
Interested in participating?
Request Info18 year–89 year
All sexes
Interventional
Not applicable
Atlanta, Georgia, 30308, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
tDCS 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
Other names: tDCS
Time frame: Baseline, day 12 post-intervention (end of treatment)
The PEG scale includes 3 questions each rated from 0 (no pain) to 10 (Pain as bad as you can imagine) over the past 24 hours. Items include average pain, interference in enjoyment, and interference in general activity. Higher score correlates with worse study outcome.
Time frame: Baseline, 3,6, and 12 months post-intervention
The PEG scale includes 3 questions each rated from 0 (no pain) to 10 (Pain as bad as you can imagine) over the past week. Items include average pain, interference in enjoyment, and interference in general activity. Higher score correlates with worse study outcome.
Contact information is provided by the study sponsor or research team.
Emory University
Other
Reboot Pain: Integrating Neuromodulation Into Clinical Care for Military and Veterans With Chronic Pain
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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