NCT03418129

Neuromodulatory Treatments for Pain Management in TBI

Neuromodulatory Treatments for Pain Management in Veterans With Complex TBI Using Mobile Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Chronic Pain
• Traumatic Brain Injury
• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
DEVICE	Mindfulness	Neuromodulatory intervention for pain management
DEVICE	Neurofeedback	Neuromodulatory intervention for pain management
DEVICE	Relaxation	Neuromodulatory intervention for pain management

Timeline

• Start date: 2018-09-05
• Primary completion: 2022-05-26
• Completion: 2022-08-26
• First posted: 2018-02-01
• Last updated: 2023-07-27
• Results posted: 2023-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study