Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery in Persons with Chronic SCI: The BO2ST Trial
Abstract
Objectives and Rationale: Currently, there is no known cure for spinal cord injury (SCI), and no single treatment is sufficient to overcome the mobility limitations that restrict functional independence. Treatment options and recovery are especially limited for those living with chronic SCI. Thus, there is a critical need to establish novel treatment strategies that improve the recovery of walking ability and that increase the probability of community walking. Both improvements will greatly reduce the health care costs for patients, their families, and payers/insurers as well as improve their overall quality of life. Task-specific training (skill-based walking practice, WALK) is now a routine treatment to reduce walking deficits after SCI. Recent therapies have combined non- invasive spinal stimulation with walking practice (WALK<tSTIM>) to promote greater recovery for persons with subacute (less than 1 year) SCI with promising results. This is likely due to an increased production of key proteins at the sub-acute injury phase that strengthen connections within the spinal cord and help the nervous system restore lost functional movements. Unfortunately, these gains are less apparent in persons with long-term (chronic) SCI when production of these proteins slow down. Our prior studies in rodents and humans with chronic SCI showed that breathing low oxygen for brief periods (termed acute intermittent hypoxia, AIH) triggers rapid production of these proteins, leading to walking recovery. We propose The BO2ST Trial to evaluate the safety, efficacy, and potency of daily treatment of Breathing low oxygen (O<2>) for brief periods to enhance Stimulation Training (WALK<tSTIM>) in persons with chronic SCI. We hypothesize that the combination of these treatments will safely boost functional mobility more than either alone. Who Are We helping? Currently there is no known cure for spinal cord injury (SCI) and health-care expenditures associated with injury-related treatment and services cost upwards of $1.5-$4.6 million. Further, treatment options for those with life-long (chronic) SCI are limited. While WALK<tSTIM> alone can improve functional benefits for those with subacute SCI, the benefits of this therapy alone for those with chronic SCI are less impactful. Based on exciting pilot data, we predict that AIH+WALK<tSTIM> will improve functional recovery for individuals with chronic SCI, addressing a critical gap in treatment options for this population. What Are the Potential Benefits? From our proposed study, we expect to obtain clinical data for the following: (a) understand if combined AIH+WALK<tSTIM> treatments improve recovery and mobility for individuals with chronic SCI beyond improvements resulting from the use of either treatment on its own, and (b) understand if the treatment combination has any adverse effects. We hypothesize that AIH+WALK<tSTIM> may allow for improved functional outcomes with shorter periods of therapy, thus improving treatment times and outcomes for those with chronic SCI and potentially reducing cost burdens to the individual and their providers. If proven beneficial, these results will allow for clinical adoption of the combined AIH+WALK<tSTIM> treatment for the large population of individuals living with chronic SCI. There is risk of localized pain due to stimulation, which will be minimized by selecting appropriate stimulation parameters that can minimize pain. What Is the Timeline? The proposed study is a multi-site, randomized clinical trial and participants will be enrolled in the study for approximately 3 months. In our proposed 4-year timeline, we expect to complete treatments and outcome tests for 60 persons with chronic SCI. Upon completion, we will have obtained clinical data on the potential functional mobility benefits of combined AIH+WALK<tSTIM> for individuals with chronic SCI. How Proposed Research Will Benefit Service Members, Veterans, Civilians, and Care
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210998
Entities
People
- Randy D Trumbower
Organizations
- Spaulding Rehabilitation Hospital
- United States Army