Status:
RECRUITING
Low Oxygen Therapy to Enhance Walking Recovery After SCI.
Lead Sponsor:
Spaulding Rehabilitation Hospital
Collaborating Sponsors:
United States Department of Defense
Brooks Rehabilitation
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 co...
Detailed Description
The goal of the study is to determine the optimal dosage for different age groups of repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) combined ...
Eligibility Criteria
Inclusion
- 18 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
- 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
Key Trial Info
Start Date :
June 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06521723
Start Date
June 6 2025
End Date
September 30 2028
Last Update
December 3 2025
Active Locations (2)
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1
Brooks Rehabilitation Hospital
Jacksonville, Florida, United States, 32216
2
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, United States, 02128