CompletedNot Applicable

Neuromodulatory Treatments for Pain Management in TBI

United States254 participantsStarted 2018-09-05

Plain-language summary

Traumatic brain injury (TBI) and chronic pain are common and serious health problems for military veterans and often co-occur, leading to poor post-deployment adjustment. Pharmacological treatments for pain elevate risk of opioid abuse, and research suggests veterans perceive barriers to existing non-pharmacological, clinic-based treatments. Thus, there is an urgent need to develop pain management approaches that are effective, overcome barriers to care, and are readily usable by Veterans. Evidence suggests that neuromodulatory treatments, grounded in understanding of neurophysiological mechanisms of pain, reduce pain-related symptoms and have the potential to be developed into self-directed treatments through use of mobile technology.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Served in one of the military branches (Army, Navy, Marines, Air Force, or Coast Guard) since October 2001.
✓. Diagnosis of Traumatic Brain Injury (TBI), defined as a traumatically induced structural injury or physiological disruption of brain function, as a result of an external force, that is indicated by new or onset or worsening of at least one of the following signs immediately following the event:
✓. Reports chronic musculoskeletal and/or neuropathic pain, defined as moderate or severe pain (≥ 4 on a 0-10 rating scale) in one or more body regions for the previous 3 months or more. For individuals on pain medication, inclusion criteria are that (a) their pain medication regimen has been stable for the past 4 weeks, (b) they do not expect any major changes in their pain medication regimen for the duration of the study, and (c) they do not expect to have surgery or to be hospitalized for pain treatment for the duration of the study.

Exclusion criteria

✕. History of epilepsy, seizure disorder, or any seizure or epileptic fit.
✕. Unable to provide informed consent.

What they're measuring

Change in Self-reported Pain Intensity

Timeframe: Baseline and 12 weeks

Trial details

NCT IDNCT03418129

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-26

Results submitted2023-05-02

View on ClinicalTrials.gov More Chronic Pain trials