Neuromodulatory Treatments for Pain Management in TBI
CompletedNot applicableNCT03418129
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Neuromodulatory Treatments for Pain Management in Veterans With Complex TBI Using Mobile Technology
- Interventions
- Device: Mindfulness
- Device: Neurofeedback
- Device: Relaxation
- Sponsor
- Duke University
- Collaborators
- United States Department of Defense
- Start date
- 2018-09-05
- Primary completion
- 2022-05-26
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Served in one of the military branches (Army, Navy, Marines, Air Force, or Coast Guard) since October 2001. 2. 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: * Any alteration in mental status (e.g. confusion, disorientation, slowed thinking, etc.) * Any loss of memory for events immediately before or after the injury. * Any period of loss or a decreased level of consciousness, observed or self-reported. 3. 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: 1. History of epilepsy, seizure disorder, or any seizure or epileptic fit. 2. Unable to provide informed consent.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03418129