Safety and feasibility of a combined neuromodulation and yoga intervention for individuals with mild traumatic brain injury and chronic pain: a pilot study

The complex clinical presentation of patients with mild traumatic brain injury and chronic pain (mTBI+CP) often causes symptoms that are resistant to standard treatments. For the first time, our team combined intermittent theta burst stimulation and yoga (iTBS+LYB) to maximize treatment effect and promote functional recovery in a pilot open-label clinical trial among Veterans with mTBI+CP. A 3-minute iTBS protocol was delivered including 3 pulses of stimulation given at 50Hz, repeated every 200ms at 80% of the resting MT, with an inter-pulse-interval of 20ms. A 2s train of iTBS was repeated every 10s for a total of 190s, for a total of 600 pulses. After all participants received iTBS, a certified yoga instructor guided a 90-minute group LYB session. N=19 participants were enrolled; 71.4% (10/14) completed all 6 iTBS+LYB sessions. Three individuals experienced headaches, a known side effect of iTBS, which resulted in one participant self-withdrawing. iTBS+LYB for mTBI+CP is feasible and safe, with known side effects. ### Competing Interest Statement KD is employed by the LoveYourBrain Foundation, a nonprofit, for whom she led the design of the curriculum for the LoveYourBrain Yoga program. KD is married to the Executive Director of the LoveYourBrain Foundation. KK is a volunteer for the LYB Foundation, serving as a Clinical Connector to raise awareness amongst patients about the opportunities LYB offers. AA, RS, SC, SB, BE, SB, IK, AB, KC, SK, TLP, and DB have no relationships or activities that could appear to have influenced the submitted work. The authors alone are responsible for the content and writing of the paper. ### Clinical Trial NCT04517604 ### Clinical Protocols ### Funding Statement The study funded by a VA Rehabilitation Research & Development Small Projects in Rehabilitation Research (SPiRE) grant which began on 12/1/2020 (I21RX003611) and the Edward Hines Jr., VA CARES SERWA grant. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: IRB of Edward Hines, Jr VA Hospital gave ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All deidentified data produced in the present study are available upon reasonable request to the authors.