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

NCT03922802 | Completed Results FDA Device

• 1 other identifier: STU00211806
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Keywords

Spinal Cord Injury; Stimulation; Spinal Stimulation; Noninvasive stimulation; Acute intermittent hypoxia; Hypoxia

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  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

  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)

Study Arms (3)

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

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.

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.

Other: Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training

Interventions

Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training OTHER

Subjects will perform locomotor activities with transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia

Also known as: SHAM AIH + tSCS + Gait

Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training

Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training OTHER

Subjects will perform locomotor activities with sham transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia

Also known as: SHAM AIH + SHAM tSCS + Gait

Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training

Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training DEVICE

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.

Also known as: AIH + tSCS+ Gait

Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases; Hypoxia

Interventions

Insemination, Artificial, Homologous; Gait

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Kelly Mckenzie, Research Physical Therapist
• Organization: Shirley Ryan AbilityLab

kmckenzie@sralab.org

31223872111

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Max Nader Laboratory

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: December 1, 2020
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: January 13, 2026
• Results First Posted: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)