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Neuromodulatory Treatments for Pain Management in TBI

NCT03418129 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2023-07-27

Study results available
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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.

Conditions

Interventions

DEVICE

Mindfulness

Neuromodulatory intervention for pain management

DEVICE

Neurofeedback

Neuromodulatory intervention for pain management

DEVICE

Relaxation

Neuromodulatory intervention for pain management

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Duke University

    lead OTHER

Principal Investigators

  • Eric Elbogen, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2022-05-26
Completion
2022-08-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03418129 on ClinicalTrials.gov