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

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. CLINICALTRIAL This protocol was prospectively registered on ClinicalTrials.gov (NCT04517604).