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Low Oxygen Therapy to Enhance Walking Recovery After Spinal Cord Injury

This study is exploring whether combining brief periods of low oxygen (acute intermittent hypoxia), electrical stimulation to the spinal cord (transcutaneous spinal cord stimulation), and walking training can improve walking ability for people with chronic spinal cord injuries. You might be able to join if you are 18 to 80 years old, medically stable, and have a spinal cord injury at or below C1 and at or above L2 with some feeling or movement below the injury. The study aims to see if this combination helps you walk better, measured by how far you can walk in 10 meters. The study is currently enrolling 60 participants, but its overall status is unclear.

Study design
This interventional study plans to enroll 60 participants. It is not specified if it is randomized or blinded.
What's involved
You would participate in 16 sessions of daily acute intermittent hypoxia over four weeks. You would also have 45 minutes of gait training with transcutaneous spinal cord stimulation.
Compensation
Not stated in the trial record.
Follow-up
Walking recovery will be assessed through study completion, an average of 14 weeks.

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NCT06521723

Low Oxygen Therapy to Enhance Walking Recovery After SCI.

Recruiting
NAAges 18–80InterventionalTreatment
Spaulding Rehabilitation Hospital
~60 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Daily acute intermittent hypoxiaWalking + tSTIM

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in walking recovery, assessed by 10 meter walk test (10MWT)
Measured over Through study completion, an average of 14 weeks
+1 more outcome measured

Conditions

Spinal Cord Injuries

Explore related trials

Spinal Cord Injury

Where it's being run

2 sites across 2 states
Florida1
Massachusetts1

Study leadership

  • Randy Trumbower, PT, PhD · PRINCIPAL_INVESTIGATOR · Harvard Medical School (HMS and HSDM)

Who to contact

Noah Piazza
[email protected]
(617) 952-6953
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Change in walking recovery, assessed by 10 meter walk test (10MWT)Through study completion, an average of 14 weeks

    Participants walk ten meters without assistance at their fastest, but safest speed with a minimum of 1-minute of rest between two trials. Average speed across the up to three 10MWT trials will be used for analysis. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.

  • Rate of change in walking recovery, assessed by 10 meter walk test (10MWT)Through study completion, an average of 14 weeks

    Participants walk ten meters without assistance at their fastest, but safest speed with a minimum of 1-minute of rest between two trials. Average speed across the up to three 10MWT trials will be used for analysis. Rate of change is the number of treatment sessions required to achieve an increase in 10MWT speed of at least the minimal clinically important difference (0.06 m/s) as compared to pre-treatment baseline.