Neuromodulatory Treatments for Pain Management in TBI
1 other identifier
interventional
254
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Sep 2018
Longer than P75 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2017
CompletedFirst Posted
Study publicly available on registry
February 1, 2018
CompletedStudy Start
First participant enrolled
September 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2022
CompletedResults Posted
Study results publicly available
July 27, 2023
CompletedJuly 27, 2023
July 1, 2023
3.7 years
November 3, 2017
May 2, 2023
July 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Self-reported Pain Intensity
Measured by the Defense and Veterans Pain Rating Scale (DVPRS), a graphic tool to facilitate self-reported pain rating using a scale from 0-10, 0 being "no pain" to 10 being "as bad as it could be, nothing else matters."
Baseline and 12 weeks
Secondary Outcomes (1)
Change in EEG Alpha Power
0 and 12 weeks
Other Outcomes (1)
Change in Self-reported Pain Intensity
Baseline and 24 weeks
Study Arms (3)
Mobile App Mindfulness
EXPERIMENTALParticipants engage in the use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Mobile App Neurofeedback
EXPERIMENTALParticipants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Mobile App Relaxation
EXPERIMENTALParticipants engage in use of a mobile application on an iPod Touch for a minimum of 10 minutes a day, 4 days a week for a total of 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of epilepsy, seizure disorder, or any seizure or epileptic fit.
- Unable to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- United States Department of Defensecollaborator
Study Sites (1)
Duke University Medical Center, Department of Psychiatry
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the COVID pandemic, EEG measurement was discontinued March 2020. As a result, although all available data are provided, less than half the sample had EEG data collected and therefore analyses of this outcome measure were not powered according to original power estimates. Consequently, there can be very limited interpretation of this data.
Results Point of Contact
- Title
- Eric Elbogen, Ph.D.
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Elbogen, PhD
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2017
First Posted
February 1, 2018
Study Start
September 5, 2018
Primary Completion
May 26, 2022
Study Completion
August 26, 2022
Last Updated
July 27, 2023
Results First Posted
July 27, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- A contribution will be submitted after study completion and will remain in the FITBIR database indefinitely.
- Access Criteria
- Only individuals with a FITBIR account who have submitted a Data Access Request that has been reviewed by the Data Access Quality Committee will be able to view the data.
Per FITBIR (Federal Interagency Traumatic Brain Injury Research) policy on Data Sharing, we will submit all de-identified data to FITBIR after the completion of the study. All data are submitted in accord with applicable laws and regulations, and that the identities of research participants will not be disclosed to the FITBIR Informatics System. FITBIR Data Sharing Policy includes steps to protect the interests and privacy concerns of individuals, families, and identifiable groups who participate in TBI genetic and other research.