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Completed

NCT Number: NCT03922802

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Hypoxia Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

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.

Other names: AIH + tSCS+ Gait

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

Other names: SHAM AIH + tSCS + Gait

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

Other names: SHAM AIH + SHAM tSCS + Gait

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

    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)

  2. 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)

    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)

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • University of California, Los Angeles

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2019
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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