RecruitingNot ApplicableNCT06521723

Low Oxygen Therapy to Enhance Walking Recovery After SCI.

Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery for Aging Adults With Chronic SCI: The BO2ST-II Trial

Sponsor

Spaulding Rehabilitation Hospital

Enrollment

60 participants

Start Date

Jun 6, 2025

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injuries

Summary

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 of different age groups.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

to 80 years of age
medically stable with medical clearance from study physician to participate
SCI at or below C1 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 Criteria11

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

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Interventions

OTHERDaily acute intermittent hypoxia

Each participant will be exposed to 16 sessions of daily acute intermittent hypoxia via air generators over the span of four weeks. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes which include intervals of 1.5 minute hypoxia (FIO2=0.10±0.02, i.e. 10% O2) and 1 minute normoxia (FIO2=0.21±0.02).

DEVICEWalking + tSTIM

Individuals will participate in 45 minutes of gait training while having transcutaneous spinal cord stimulation. Stimulation intensity will be 80% involuntary motor threshold.