Neuromodulatory Treatments for Pain Management in TBI
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain, Neurology, Psychiatric |
| Therapuetic Areas: | Musculoskeletal, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/18/2018 |
| Start Date: | September 5, 2018 |
| End Date: | February 1, 2021 |
| Contact: | Eric Elbogen, PhD |
| Email: | vetstudy@duke.edu |
| Phone: | 919-684-9983 |
Neuromodulatory Treatments for Pain Management in Veterans With Complex TBI Using Mobile Technology
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.
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.
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 will be scheduled for a baseline interview at the Duke Behavioral Health
and Technology Lab after passing a preliminary telephone screen. After providing informed
consent, participants will provide data on clinical measures. Electroencephalography (EEG)
will be used to measure brain activity. Following data collection, participants will be
assigned to one of three groups (n=100 in each). Each group will receive an iPod Touch with a
different mobile application (app), which participants will be instructed to use for 10
minute a day, 4 times a week for 12 weeks. Study coordinators will conduct two home visits
(week 1 and week 6) and two phone calls (week 3 and week 9) to reinforce training,
troubleshoot difficulties, and ask about intervention utilization. Follow-up data on clinical
measures and EEG will be collected at 12 weeks and again at 24 weeks.
treatments for chronic pain, for post-9/11 veterans with co-occuring pain and TBI. Three
hundred participants will be scheduled for a baseline interview at the Duke Behavioral Health
and Technology Lab after passing a preliminary telephone screen. After providing informed
consent, participants will provide data on clinical measures. Electroencephalography (EEG)
will be used to measure brain activity. Following data collection, participants will be
assigned to one of three groups (n=100 in each). Each group will receive an iPod Touch with a
different mobile application (app), which participants will be instructed to use for 10
minute a day, 4 times a week for 12 weeks. Study coordinators will conduct two home visits
(week 1 and week 6) and two phone calls (week 3 and week 9) to reinforce training,
troubleshoot difficulties, and ask about intervention utilization. Follow-up data on clinical
measures and EEG will be collected at 12 weeks and again at 24 weeks.
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. Women who report being pregnant or breastfeeding, report plans to become pregnant or
begin breastfeeding in the next six months, or who have a positive result on a urine
pregnancy test administered at the baseline interview.
3. Unable to provide informed consent.
We found this trial at
1
site
Durham, North Carolina 27705
Principal Investigator: Eric Elbogen, PhD
Phone: 919-681-1613
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