Spinal Cord InjuriesNCT03922802

SCI Acute Intermittent Hypoxia and Non-Invasive Spinal Stimulation Combined With Gait Training

A study testing Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Shirley Ryan AbilityLab at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single blind, sham controlled crossover trial that will evaluate the effectiveness of acute intermittent hypoxia therapy (AIH) combined with transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals after spinal cord injury. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Cord Injuries, Spinal Cord Diseases
What is being tested?: Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2020to 3 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants have been diagnosed with a spinal cord injury below level C2
ASIA Impairment Scale Grade A-D
Participants are 18 years of age or older
Participants are at least 6 months post spinal cord injury
Participants with paraplegia or tetraplegia secondary to a single spinal cord injury
Participants are able to provide informed consent
Participants are not currently receiving regular physical therapy services

Who cannot join

Individuals less than 18 years of age
Individuals less than 6 months post spinal cord injury
Individuals with ataxia
Individuals with multiple spinal cord injury history
Pregnancy or nursing
Pacemaker or anti-spasticity implantable pumps

Show all 26Show fewer

Active pressure sores
Unhealed bone fractures
Peripheral neuropathies
Painful musculoskeletal dysfunction due to active injuries or infections
Severe contractures in the lower extremities
Active urinary tract infection
Clinically significant depression, psychiatric disorders, or ongoing drug abuse
Diagnosed with any of the following medical conditions: congestive heart failure, cardiac arrhythmias, uncontrolled hypertension, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction, or known carotid/intracerebral artery stenosis
Individuals with a tracheostomy or who utilize mechanical ventilation.
Individuals who are currently enrolled in another interventional research study or in therapy related to upper extremity function.
Participants will be excluded if they have had a botulinum toxin injection to lower extremity musculature within the last 3 months. Participants will need to refrain from lower extremity botulinum toxin injections for the duration of the study. If participants wean off antispasticity medications to successfully complete the responsiveness to AIH screening session, they will need to refrain from the medications for the duration of the study.
Documented sleep apnea.
Orthopedic injuries or surgeries that would impact an individual's ability to use the lower extremity.
Traumatic brain injury or other neurological conditions that would impact the study.
Blood hemoglobin levels less than 10g/dL.
We will not include the following populations:
Adults unable to consent, unless accompanied by a legally authorized representative.
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

Shirley Ryan AbilityLab
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Locomotor Function Following Acute Intermittent Hypoxia (AIH) and Transcutaneous Electrical Spinal Cord Stimulation (tSCS) With Gait Therapy Versus Traditional Gait Therapy in Individuals With Spinal Cord Injury

Read the detailed description

OBJECTIVES:

To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training modulates spinal locomotor networks in individuals with spinal cord injury
To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves locomotor function in individuals with spinal cord injury
To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves symmetry of gait in individuals with spinal cord injury
To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves standing posture and balance in individuals with spinal cord injury
To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with a combination of AIH, transcutaneous spinal cord stimulation and ambulation training in individuals with spinal cord injury

Conditions: Spinal Cord Injuries, Spinal Cord Diseases
Being tested: Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training, Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training, Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
Keywords: Spinal Cord Injury, Stimulation, Spinal Stimulation, Noninvasive stimulation, Acute intermittent hypoxia, Hypoxia
Medical subject headings: Spinal Cord Injuries, Spinal Cord Diseases, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait TrainingDevice
Also called AIH + tSCS+ Gait
Subjects will receive up to 45 minutes of AIH prior to receiving transcutaneous electrical spinal cord stimulation delivered by a Transcutaneous Spinal Cord Neurostimulator while performing locomotor activities.
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait TrainingOther
Also called SHAM AIH + tSCS + Gait
Subjects will perform locomotor activities with transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait TrainingOther
Also called SHAM AIH + SHAM tSCS + Gait
Subjects will perform locomotor activities with sham transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia

Study groups in NCT03922802
Study group	Role	What they receive
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training	Experimental	May receive up to 45 minutes of AIH prior to up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Intervention: Device: AIH prior to Noninvasive spinal stimulation during gait training Receives: Device: Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training	Sham comparator	May receive up to 45 minutes of Sham AIH prior to up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Receives: Other: Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training	Sham comparator	May receive up to 45 minutes of Sham AIH prior to up to 50 min of locomotion training with sham transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Receives: Other: Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in 6 Minute Walk Test
The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assertive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test was completed at 4 time points within each arm: 1) Baseline prior to starting each arm, 2) intervention session 5 within each arm (T5), 3) 3 days after the intervention sessions were complete for the given arm (POST), and 4) 1 week after all intervention sessions were complete for a given arm (1-week follow up)
Measured: Baseline (initial visit within an arm), Intervention session 5 within each arm (T5), 3 days after intervention sessions complete within each arm (POST), 1 week after intervention sessions are complete within each arm (1-week follow up)

Secondary outcomes (2)

Change in 10 Meter Walk Test, Fast Velocity
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed: 1) Baseline prior to starting each arm, 2) intervention session 5 within each arm (T5), 3) 3 days after the intervention sessions were complete for the given arm (POST), and 4) 1 week after all intervention sessions were complete for a given arm (1-week follow up)
Measured: Baseline (initial visit within an arm), Intervention session 5 within each arm (T5), 3 days after intervention sessions complete within each arm (POST), 1 week after intervention sessions are complete within each arm (1-week follow up)
Timed Up and Go Test: Assesses Mobility, Balance, Walking Ability and Fall Risk
The participant starts seated in a chair with his/her back against the chair back. On command, the participant rises from the chair, walks 3 meters, turns, walks back to the chair and sits down. Timing begins when the command to start is given and stops when the participant returns to a seated position. 1) Baseline prior to starting each arm, 2) intervention session 5 within each arm (T5), 3) 3 days after the intervention sessions were complete for the given arm (POST), and 4) 1 week after all intervention sessions were complete for a given arm (1-week follow up)
Measured: Baseline (initial visit within an arm), Intervention session 5 within each arm (T5), 3 days after intervention sessions complete within each arm (POST), 1 week after intervention sessions are complete within each arm (1-week follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20203 Jan 2023

First posted22 Apr 2019
Study start1 Dec 2020
Primary completion3 Jan 2023
Study completion3 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03922802
Sponsor's protocol ID: STU00211806
Status last verified: Dec 2025
First submitted: 17 Apr 2019
Last updated: 13 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Locomotor Function Following Acute Intermittent Hypoxia (AIH) and Transcutaneous Electrical Spinal Cord Stimulation (tSCS) With Gait Therapy Versus Traditional Gait Therapy in Individuals With Spinal Cord Injury
ClinicalTrials.gov ID: NCT03922802
Acronym / sponsor ID: STU00211806
Conditions: Spinal Cord Injuries, Spinal Cord Diseases
Keywords: Spinal Cord Injury, Stimulation, Spinal Stimulation, Noninvasive stimulation, Acute intermittent hypoxia, Hypoxia
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Shirley Ryan AbilityLabUniversity, hospital or other
Collaborators: University of California, Los Angeles
Study start: 1 Dec 2020 (actual)
Primary completion: 3 Jan 2023 (actual)
Study completion: 3 Jan 2023 (actual)
First posted: 22 Apr 2019 (actual)
Results: Posted 13 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training modulates spinal locomotor networks in individuals with spinal cord injury
To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves locomotor function in individuals with spinal cord injury
To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves symmetry of gait in individuals with spinal cord injury
To determine whether acute intermittent hypoxia therapy (AIH) combined with transcutaneous spinal cord stimulation during ambulation training improves standing posture and balance in individuals with spinal cord injury
To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with a combination of AIH, transcutaneous spinal cord stimulation and ambulation training in individuals with spinal cord injury

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training	Experimental	Device: Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait TrainingMay receive up to 45 minutes of AIH prior to up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Intervention: Device: AIH prior to Noninvasive spinal stimulation during gait training
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training	Sham comparator	Other: Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait TrainingMay receive up to 45 minutes of Sham AIH prior to up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training	Sham comparator	Other: Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait TrainingMay receive up to 45 minutes of Sham AIH prior to up to 50 min of locomotion training with sham transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Participants have been diagnosed with a spinal cord injury below level C2
ASIA Impairment Scale Grade A-D
Participants are 18 years of age or older
Participants are at least 6 months post spinal cord injury
Participants with paraplegia or tetraplegia secondary to a single spinal cord injury

Key exclusion criteria (26 listed)

Individuals less than 18 years of age
Individuals less than 6 months post spinal cord injury
Individuals with ataxia
Individuals with multiple spinal cord injury history
Pregnancy or nursing

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait TrainingAlso: AIH + tSCS+ GaitSubjects will receive up to 45 minutes of AIH prior to receiving transcutaneous electrical spinal cord stimulation delivered by a Transcutaneous Spinal Cord Neurostimulator while performing locomotor activities.	Device	Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait TrainingAlso: SHAM AIH + tSCS + GaitSubjects will perform locomotor activities with transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia	Other	Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait TrainingAlso: SHAM AIH + SHAM tSCS + GaitSubjects will perform locomotor activities with sham transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia	Other	Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training

Primary outcome

Change in 6 Minute Walk Test
Time frame: Baseline (initial visit within an arm), Intervention session 5 within each arm (T5), 3 days after intervention sessions complete within each arm (POST), 1 week after intervention sessions are complete within each arm (1-week follow up)
The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assertive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test was completed at 4 time points within each arm: 1) Baseline prior to starting each arm, 2) intervention session 5 within each arm (T5), 3) 3 days after the intervention sessions were complete for the given arm (POST), and 4) 1 week after all intervention sessions were complete for a given arm (1-week follow up)

2 secondary outcomes

Change in 10 Meter Walk Test, Fast Velocity
Time frame: Baseline (initial visit within an arm), Intervention session 5 within each arm (T5), 3 days after intervention sessions complete within each arm (POST), 1 week after intervention sessions are complete within each arm (1-week follow up)
Timed Up and Go Test: Assesses Mobility, Balance, Walking Ability and Fall Risk
Time frame: Baseline (initial visit within an arm), Intervention session 5 within each arm (T5), 3 days after intervention sessions complete within each arm (POST), 1 week after intervention sessions are complete within each arm (1-week follow up)

Results and safety

Results posted to the registry on 13 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	14	10

Primary outcome: Change in 6 Minute Walk Test

Time frame: Baseline (initial visit within an arm), Intervention session 5 within each arm (T5), 3 days after intervention sessions complete within each arm (POST), 1 week after intervention sessions are complete within each arm (1-week follow up). Mean (95% Confidence Interval). Unit: meters (m)

Measure	Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training n = 9	Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training n = 9	Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training n = 9
Baseline to T5 (7-8 days after baseline from stated arm)	19.57 (3.68 to 35.46)	12.28 (-1.58 to 26.13)	9.63 (-6.45 to 25.71)
Baseline to POST (10-11 days after baseline from stated arm)	19.03 (2.94 to 35.13)	12.01 (-7.41 to 31.44)	15.63 (6.29 to 24.98)
Baseline to 1-week follow up (17-19 days after baseline from stated arm)	21.80 (3.50 to 40.10)	10.33 (-8.33 to 29.00)	16.13 (-0.36 to 32.62)

Population analysed: 10 participants completed and analyzed. 1 was dropped from analysis as an outlier (difference of greater than 1.5\*IQR (interquartile range) for all gait outcomes) = 9 participants in analysis total.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 1-week follow up of third intervention arm (4 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arun Jayaraman, PT, PhD principal investigator

Shirley Ryan AbilityLab

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 6 Minute Walk Test (time frame: Baseline (initial visit within an arm), Intervention session 5 within each arm (T5), 3 days after intervention sessions complete within each arm (POST), 1 week after intervention sessions are complete within each arm (1-week follow up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03922802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.