Status:
COMPLETED
Neuromodulatory Treatments for Pain Management in TBI
Lead Sponsor:
Duke University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Chronic Pain
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 fo...
Detailed Description
This study is a prospective, three-arm, randomized controlled trial of neuromodulatory treatments for chronic pain, for post-9/11 veterans with co-occuring pain and TBI. Three hundred participants wil...
Eligibility Criteria
Inclusion
- 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:
- 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.
- 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
- History of epilepsy, seizure disorder, or any seizure or epileptic fit.
- Unable to provide informed consent.
Key Trial Info
Start Date :
September 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2022
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT03418129
Start Date
September 5 2018
End Date
August 26 2022
Last Update
July 27 2023
Active Locations (1)
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1
Duke University Medical Center, Department of Psychiatry
Durham, North Carolina, United States, 27705