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Neuromodulatory Treatments for Pain Management in TBI

Primary Purpose

Chronic Pain, Traumatic Brain Injury, Posttraumatic Stress Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness

Neurofeedback

Relaxation

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Military Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

History of epilepsy, seizure disorder, or any seizure or epileptic fit.
Unable to provide informed consent.

Sites / Locations

Duke University Medical Center, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Mobile App Mindfulness

Mobile App Neurofeedback

Mobile App Relaxation

Arm Description

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

Change in Self-reported Pain Intensity

Secondary Outcome Measures

Change in EEG Alpha Power

Average FFT (Fast Fourier Transform) Power (alpha 8-12 Hz) measured as sqrt(uV)/Hz.

Full Information

NCT ID

NCT03418129

First Posted

November 3, 2017

Last Updated

July 6, 2023

Sponsor

Duke University

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT03418129

Brief Title

Neuromodulatory Treatments for Pain Management in TBI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

September 5, 2018 (Actual)

Primary Completion Date

May 26, 2022 (Actual)

Study Completion Date

August 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Traumatic Brain Injury, Posttraumatic Stress Disorder

Keywords

Military Veterans

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

254 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mobile App Mindfulness

Arm Type

Experimental

Arm Description

Participants 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.

Arm Title

Mobile App Neurofeedback

Arm Type

Experimental

Arm Description

Participants 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.

Arm Title

Mobile App Relaxation

Arm Type

Experimental

Arm Description

Participants 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.

Intervention Type

Device

Intervention Name(s)

Mindfulness

Intervention Description

Neuromodulatory intervention for pain management

Intervention Type

Device

Intervention Name(s)

Neurofeedback

Intervention Description

Neuromodulatory intervention for pain management

Intervention Type

Device

Intervention Name(s)

Relaxation

Intervention Description

Neuromodulatory intervention for pain management

Primary Outcome Measure Information:

Title

Change in Self-reported Pain Intensity

Description

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Change in EEG Alpha Power

Description

Average FFT (Fast Fourier Transform) Power (alpha 8-12 Hz) measured as sqrt(uV)/Hz.

Time Frame

0 and 12 weeks

Other Pre-specified Outcome Measures:

Title

Change in Self-reported Pain Intensity

Description

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." This mean difference represents the mean change in pain intensity between 0 and 24 weeks. Please note that the analysis of results utilized a multilevel modeling (MLM) approach of all available data, which involved analyzing pain intensity data collected at 0, 12, and 24 weeks.

Time Frame

Baseline and 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: History of epilepsy, seizure disorder, or any seizure or epileptic fit. Unable to provide informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Elbogen, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center, Department of Psychiatry

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

A contribution will be submitted after study completion and will remain in the FITBIR database indefinitely.

IPD Sharing 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.

IPD Sharing URL

https://fitbir.nih.gov/

Learn more about this trial

Neuromodulatory Treatments for Pain Management in TBI

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