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Combination Therapy to Improve SCI Recovery.
Recruiting
Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery in Persons With Chronic SCI: The BO2ST Trial
Who can join
Ages 18 to 70 · All sexes
Full eligibility criteria
Inclusion Criteria: * 18 to 70 years of age * medically stable with medical clearance from study physician to participate * SCI at or below C2 (phrenic sparing) and at or above L2 with at least some sensory or motor function preserved below the neurologic level * non-progressive etiology of spinal injury * American Spinal Injury Association (ASIA) scores of C-D at initial screen * ambulatory (able to complete the 10-meter walk test without support from another person) * chronic injury (define as \> 12 months post-injury) to avoid potential for spontaneous neurological plasticity and recovery Exclusion Criteria: * severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, severe infection (e.g., urinary tract), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis, active heterotopic ossification in the lower extremities, severe systemic inflammation * \< 24 on Mini-Mental Exam * severe recurrent autonomic dysreflexia * history of severe cardiovascular/pulmonary complications including hypertension (systolic blood pressure \> 150 mmHg) * pregnancy because of unknown effects of AIH or tSTIM on a fetus (individuals of childbearing potential will not otherwise be excluded) * botulinum toxin injections in lower extremity muscles within the prior three months * history of tendon or nerve transfer surgery in the lower extremity * untreated severe sleep-disordered breathing characterized by uncontrolled hypoxia and sleep fractionation that may impact the outcome of this study. * active implanted devices (e.g., intrathecal baclofen pump) * receiving concurrent electrical stimulation * motor threshold evoked by transcutaneous spinal stimulation \>200 mA
About the study
The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking function for people with chronic spinal cord injury.
What is being tested
- Daily acute intermittent hypoxia (other)
- Room air (SHAM) (other)
- Walking + tSTIM (other)
- Walking + Sham transcutaneous spinal stimulation (tSHAM) (other)
Sponsor: Spaulding Rehabilitation Hospital · Participants: 60 · Started: Jan 17, 2023
Contact the study team
- Noah Piazza, BS · Phone: 617-952-6953
Official record on ClinicalTrials.gov — NCT05563103
Locations in the U.S.
| Illinois | Shirley Ryan AbilityLab, Chicago |
| Massachusetts | Spaulding Rehabilitation Hospital, Cambridge |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.