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Combination Therapy to Improve Spinal Cord Injury Recovery

This study is looking at new ways to improve walking for people with chronic spinal cord injuries. Researchers want to see if combining daily acute intermittent hypoxia (brief periods of breathing low oxygen) with transcutaneous spinal cord stimulation (tSTIM, a type of electrical stimulation) and walking training can help you walk better. You might be able to join if you are 18 to 70 years old, medically stable, and have a spinal cord injury at certain levels with some feeling or movement below the injury. The study will measure how much your walking improves using a 10-meter walk test over about 12 weeks. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 60 participants. It will compare different combinations of low oxygen, room air, spinal cord stimulation, and sham stimulation.
What's involved
You would participate in 8 sessions of daily acute intermittent hypoxia or room air over two weeks. You would also have 45 minutes of gait training with either transcutaneous spinal cord stimulation or sham stimulation.
Compensation
Not stated in the trial record.
Follow-up
Your walking recovery will be assessed through study completion, which is an average of 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05563103

Combination Therapy to Improve SCI Recovery.

Recruiting
NAAges 18–70InterventionalTreatment
Spaulding Rehabilitation Hospital
~60 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Daily acute intermittent hypoxiaRoom air (SHAM)Walking + tSTIMWalking + Sham transcutaneous spinal stimulation (tSHAM)

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 12 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
Illinois1
Massachusetts1

Study leadership

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

Who to contact

Noah Piazza, BS
[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 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

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 12 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 12 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.