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Feasibility of a combined neuromodulation and yoga intervention for mild traumatic brain injury and chronic pain: Protocol for an open-label pilot trial

APA Citation:

Krese, K. A., Donnelly, K. Z., Etingen, B., Bender Paper, T. L., Chaudhuri, S., Aaronson, A. L., Shah, R. P., Bhaumik, D. K., Billups, A., Bedo, S., Wanicek-Squeo, M. T., Bobra, S., & Herrold, A. A. (2022). Feasibility of a combined neuromodulation and yoga intervention for mild traumatic brain injury and chronic pain: Protocol for an open-label pilot trial. JMIR Research Protocols., 11(6). https://doi.org/10.2196/37836

Focus:

Trauma
Physical health
Veterans

Branch of Service:

Multiple branches

Military Affiliation:

Veteran

Subject Affiliation:

Veteran

Population:

Young adulthood (18 - 29 yrs)
Adulthood (18 yrs & older)
Thirties (30 - 39 yrs)
Middle age (40 - 64 yrs)

Methodology:

Mixed Methods
Quantitative Study
Qualitative Study

Authors:

Krese, Kelly A., Donnelly, Kyla Z., Etingen, Bella, Pape, Theresa L. Bender, Chaudhuri, Sarmistha, Aaronson, Alexandra L., Shah, Rachana P., Bhaumik, Dulal K., Billups, Andrea, Bedo, Sabrina, Wanicek-Squeo, Mary Terese, Bobra, Sonia, Herrold, Amy A.

Abstract:

Background: Mild traumatic brain injury (mTBI) and chronic pain often co-occur and worsen rehabilitation outcomes. There is a need for improved multimodal nonpharmacologic treatments that could improve outcomes for both conditions. Yoga is a promising activity-based intervention for mTBI and chronic pain, and neuromodulation through transcranial magnetic stimulation is a promising noninvasive, nonpharmacological treatment for mTBI and chronic pain. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory transcranial magnetic stimulation. iTBS can induce a window of neuroplasticity, making it ideally suited to boost the effects of treatments provided after it. Thus, iTBS may magnify the impacts of subsequently delivered interventions as compared to delivering those interventions alone and accordingly boost their impact on outcomes. Objective: The aim of this study is to (1) develop a combined iTBS+yoga intervention for mTBI and chronic pain, (2) assess the intervention’s feasibility and acceptability, and (3) gather preliminary clinical outcome data on quality of life, function, and pain that will guide future studies. Methods: This is a mixed methods, pilot, open-labeled, within-subject intervention study. We will enroll 20 US military veteran participants. The combined iTBS+yoga intervention will be provided in small group settings once a week for 6 weeks. The yoga intervention will follow the LoveYourBrain yoga protocol—specifically developed for individuals with TBI. iTBS will be administered immediately prior to the LoveYourBrain yoga session. We will collect preliminary quantitative outcome data before and after the intervention related to quality of life (TBI-quality of life), function (Mayo-Portland Adaptability Index), and pain (Brief Pain Inventory) to inform larger studies. We will collect qualitative data via semistructured interviews focused on intervention acceptability after completion of the intervention. Results: This study protocol was approved by Edward Hines Jr Veterans Administration Hospital Institutional Review Board (Hines IRB 1573116-4) and was prospectively registered on ClinicalTrials.gov (NCT04517604). This study includes a Food and Drug Administration Investigational Device Exemption (IDE: G200195). A 2-year research plan timeline was developed. As of March 2022, a total of 6 veterans have enrolled in the study. Data collection is ongoing and will be completed by November 2022. We expect the results of this study to be available by October 2024. Conclusions: We will be able to provide preliminary evidence of safety, feasibility, and acceptability of a novel combined iTBS and yoga intervention for mTBI and chronic pain—conditions with unmet treatment needs.

Publisher/Sponsoring Organization:

JMIR Publications

Publication Type:

Article

Author Affiliation:

Brain Innovation Center, Shirley Ryan Ability Lab, KAK
Research and Development Service, Edward Hines Jr Veterans Administration Hospital, KAK
Research and Development Service, Edward Hines Jr Veterans Administration Hospital, AB
Research and Development Service, Edward Hines Jr Veterans Administration Hospital, DKB
Research and Development Service, Edward Hines Jr Veterans Administration Hospital, AAH
LoveYourBrain Foundation, KZD
Center for Innovation in Complex Chronic Healthcare & Research Service, Edward Hines Jr Veterans Administration Hospital, BE
Center for Innovation in Complex Chronic Healthcare & Research Service, Edward Hines Jr Veterans Administration Hospital, TLBP
Research and Development Service , Edward Hines Jr Veterans Administration Hospital, TLBP
Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University, TLBP
Department of Physical Medicine and Rehabilitation, Edward Hines Jr Veterans Administration Hospital, SC
Department of Physical Medicine and Rehabilitation, Edward Hines Jr Veterans Administration Hospital, RPS
Department of Physical Medicine and Rehabilitation, Edward Hines Jr Veterans Administration Hospital, SB
Mental Health Service Line, Edward Hines Jr Veterans Administration Hospital, ALA
Department of Psychiatry, Feinberg School of Medicine, Northwestern University, ALA
Department of Psychiatry, University of Illinois Chicago, DKB
Recreation Therapy, Edward Hines Jr Veterans Administration Hospital, SB
Recreation Therapy, Edward Hines Jr Veterans Administration Hospital, MTWS
Edward Hines Jr Veterans Administration Hospital, MTWS
Department of Radiology, Edward Hines Jr Veterans Administration Hospital, SB
Department of Radiology, Stritch School of Medicine, Loyola University Chicago, SB
Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, AAH

Keywords:

yoga therapy, traumatic brain injury, chronic pain, rehabilitation

Sponsors:

This study is funded by the Veterans Affairs Rehabilitation Research and Development Small Projects in Rehabilitation Research grant, which began on December 1, 2020 (I21RX003611).

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