Maintenance Notice

Due to necessary scheduled maintenance, the JMIR Publications website will be unavailable from Wednesday, July 01, 2020 at 8:00 PM to 10:00 PM EST. We apologize in advance for any inconvenience this may cause you.

Who will be affected?

Accepted for/Published in: JMIR Research Protocols

Date Submitted: Mar 8, 2022
Date Accepted: Mar 16, 2022

The final, peer-reviewed published version of this preprint can be found here:

Feasibility of a Combined Neuromodulation and Yoga Intervention for Mild Traumatic Brain Injury and Chronic Pain: Protocol for an Open-label Pilot Trial

Krese KA, Donnelly KZ, Etingen B, Bender Pape TL, Chaudhuri S, Aaronson AL, Shah R, Bhaumik DK, Billups A, Bedo S, Wanicek-Squeo MT, Bobra S, Herrold AA

Feasibility of a Combined Neuromodulation and Yoga Intervention for Mild Traumatic Brain Injury and Chronic Pain: Protocol for an Open-label Pilot Trial

JMIR Res Protoc 2022;11(6):e37836

DOI: 10.2196/37836

PMID: 35704372

PMCID: 9244651

Feasibility of a Combined Neuromodulation and Yoga Intervention for Mild Traumatic Brain Injury and Chronic Pain: Protocol for an Open-Label Pilot Trial

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

ABSTRACT

Background:

Mild traumatic brain injury (mTBI) and chronic pain often co-occur and worsen rehabilitation outcomes. There is a need for improved, multi-modal non-pharmacologic 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 non-invasive, non-pharmacological 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:

1) To develop a combined iTBS+yoga intervention for mTBI and chronic pain, 2) to assess the intervention’s feasibility and acceptability, and 3) to 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 a total of 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-QOL), function (Mayo Portland Adaptability Index) and pain (Brief Pain Inventory) to inform larger studies. We will collect qualitative data via semi-structured interviews focused on intervention acceptability after completion of the intervention.

Results:

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.

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. Clinical Trial: This protocol was prospectively registered on ClinicalTrials.gov (NCT04517604).


 Citation

Please cite as:

Krese KA, Donnelly KZ, Etingen B, Bender Pape TL, Chaudhuri S, Aaronson AL, Shah R, Bhaumik DK, Billups A, Bedo S, Wanicek-Squeo MT, Bobra S, Herrold AA

Feasibility of a Combined Neuromodulation and Yoga Intervention for Mild Traumatic Brain Injury and Chronic Pain: Protocol for an Open-label Pilot Trial

JMIR Res Protoc 2022;11(6):e37836

DOI: 10.2196/37836

PMID: 35704372

PMCID: 9244651

Download PDF


Request queued. Please wait while the file is being generated. It may take some time.

© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.