Chronic PainNCT03418129
Neuromodulatory Treatments for Pain Management in TBI
A study testing Mindfulness, Neurofeedback and Relaxation in people with Chronic Pain and Traumatic Brain Injury, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Traumatic Brain Injury, Posttraumatic Stress Disorder
- What is being tested?
- Mindfulness, Neurofeedback and Relaxation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2018to 26 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of epilepsy, seizure disorder, or any seizure or epileptic fit.
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center, Department of Psychiatry
Durham, North Carolina, 27705
About this study
Official title: 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.
Read the 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.
- Being tested
- Mindfulness, Neurofeedback, Relaxation
- Keywords
- Military Veterans
- Medical subject headings
- Chronic Pain, Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessDevice
Neuromodulatory intervention for pain management
NeurofeedbackDevice
Neuromodulatory intervention for pain management
RelaxationDevice
Neuromodulatory intervention for pain management
| Study group | Role | What they receive |
|---|---|---|
| Mobile App Mindfulness | Experimental | 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. Receives: Device: Mindfulness |
| Mobile App Neurofeedback | Experimental | 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. Receives: Device: Neurofeedback |
| Mobile App Relaxation | Experimental | 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. Receives: Device: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Change in EEG Alpha Power
Average FFT (Fast Fourier Transform) Power (alpha 8-12 Hz) measured as sqrt(uV)/Hz.
Measured: 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start5 Sep 2018
- Primary completion26 May 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Eric Elbogen, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418129
- Sponsor's protocol ID
- Pro00088360
- Status last verified
- Jul 2023
- First submitted
- 3 Nov 2017
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulatory Treatments for Pain Management in Veterans With Complex TBI Using Mobile Technology
- ClinicalTrials.gov ID
- NCT03418129
- Acronym / sponsor ID
- Pro00088360
- Keywords
- Military Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mobile App Mindfulness | Experimental | Device: MindfulnessParticipants 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 | Experimental | Device: NeurofeedbackParticipants 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 | Experimental | Device: RelaxationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (2 listed)
- History of epilepsy, seizure disorder, or any seizure or epileptic fit.
- Unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessNeuromodulatory intervention for pain management | Device | Mobile App Mindfulness |
| NeurofeedbackNeuromodulatory intervention for pain management | Device | Mobile App Neurofeedback |
| RelaxationNeuromodulatory intervention for pain management | Device | Mobile App Relaxation |
Primary outcome
Change in Self-reported Pain Intensity
Time frame: Baseline and 12 weeks
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."
1 secondary outcome
Change in EEG Alpha Power
Time frame: 0 and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Elbogen, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness, Neurofeedback and Relaxation in people with Chronic Pain and Traumatic Brain Injury, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-reported Pain Intensity (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.