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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

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

Clinicaltrials.gov identifier NCT03922802

Recruitment Status Not yet recruiting

First Posted April 22, 2019

Last update posted September 1, 2020

Study Description

Brief summary:

This is a randomized control 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.

  • Condition or Disease:Spinal Cord Injuries
    Spinal Cord Diseases
  • Intervention/Treatment: Device: AIH prior to noninvasive spinal stimulation during gait training
    Other: Conventional Gait Training
  • Phase: N/A
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
  • Study Type: Interventional
  • Estimated Enrollment: 36 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Estimated Study Start Date: October 2021
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Noninvasive Spinal Stimulation with Hypoxia + Gait Training
May receive up to 45 minutes of AIH and 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: AIH prior to noninvasive spinal stimulation during gait training
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.
Active Comparator: Conventional Gait Training
May receive up to 50 min of locomotion training without hypoxia or 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: Conventional Gait Training
Subjects will perform locomotor activities without AIH or transcutaneous electrical spinal cord stimulation
Outcome Measures
  • Primary Outcome Measures: 1. Change in Gait Symmetry [ Time Frame: Session 1 (baseline test, initial visit), After 4 weeks of intervention (Mid Point), After 8 weeks of intervention (Post intervention), 3 month follow-up, 6 month follow-up, 12 month follow-up] ]
    Participants will ambulate along Gait Rite electronic walkway 6 times (3 times per gait speed) to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The Gait Rite electronic walkway contains sensor pads encapsulated in a carpet and connected to a computer. The system can be laid over any flat surface and automates measuring temporal and spatial gait parameters. The Gait Rite electronic walkway for the study shall be a minimum of 14 feet long. The Gait Rite data capture was chosen as measurement of the patient's overall gait quality.
  • Secondary Outcome Measures: 1. Change in 10 Meter Walk Test [ Time Frame: Session 1 (baseline test, initial visit), After 4 weeks of intervention (Mid Point), After 8 weeks of intervention (Post intervention), 3 month follow-up, 6 month follow-up, 12 month follow-up] ]
    This test will examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed.
  • 2. Change in 6 Minute Walk Test Using VO2 Analysis [ Time Frame: Session 1 (baseline test, initial visit), After 4 weeks of intervention (Mid Point), After 8 weeks of intervention (Post intervention), 3 month follow-up, 6 month follow-up, 12 month 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 test will be used to determine participant's gait efficiency at baseline and at study completion. 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 will be administered while wearing a portable gas analysis system called the Cosmed K4B2 to measure oxygen consumption. This system measures oxygen consumption (VO2) and Carbon-dioxide production (VCO2) in a breath by breath fashion.
  • 3. Change in intra and inter limb coordination using Electromyography (EMG) [ Time Frame: Session 1 (baseline test, initial visit), After 4 weeks of intervention (Mid Point), After 8 weeks of intervention (Post intervention), 3 month follow-up, 6 month follow-up, 12 month follow-up] ]
    Locomotion assessment for inter and intra limb coordination using wearable sensors and EMG sensors. Participants ambulate along Gait Rite electronic walkway up to 12 times (3 times per gait speed with and without lower extremity orthotics if safe and appropriate) to evaluate gait pattern at both self-selected and safe fast gait speed.
  • 4. Change in Spinal Motor Evoked Potentials (MEPs) [ Time Frame: Session 1 (baseline test, initial visit), After 4 weeks of intervention (Mid Point), After 8 weeks of intervention (Post intervention), 3 month follow-up, 6 month follow-up, 12 month follow-up] ]
    Spinal Motor Evoked Potentials (MEPs) will be obtained by stimulating the spinal cord between spinous processes of up to 5 vertebrae with a single pulse. MEPs are the electromyograph responses of the peripheral muscles to electrical stimulation of the spinal cord. MEPs will be used to test the integrity of the motor pathways of the spinal cord. A Transcutaneous Spinal Cord Neurostimulator (BioStim-5 or NeuroEnabling Stimulator System) will deliver transcutaneous electrical spinal cord stimulation.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

- Participants who demonstrate at least a 10% change in isometric or isokinetic
plantarflexion, dorsiflexion or knee extension force above baseline after a single
bout of Acute Intermittent Hypoxia (AIH) during screening

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

- Modified Ashworth score of 3 or greater in lower extremity

- 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

Contacts and Locations
Contacts

Contact: Kelly A McKenzie, PT, DPT, NCS 312-238-7111 kmckenzie@sralab.org

Contact: Lindsey Yingling, PT, DPT, NCS 312-238-1063 lyingling@sralab.org

Locations

United States, Illinois
Shirley Ryan AbilityLab
Chicago

Sponsors and Collaborators

Shirley Ryan AbilityLab

University of California, Los Angeles

Investigators

Principal Investigator: Arun Jayaraman, PT, PhD Shirley Ryan AbilityLab

More Information
  • Responsible Party: Shirley Ryan AbilityLab
  • ClinicalTrials.gov Identifier: NCT03922802 History of Changes
  • Other Study ID Numbers: STU00211806
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: September 1, 2020
  • Last Verified: August 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Shirley Ryan AbilityLab: Spinal Cord Injury
    Stimulation
    Acute intermittent hypoxia
    Hypoxia
    Spinal Stimulation
    Noninvasive stimulation
  • Additional relevant MeSH terms: Spinal Cord Injuries
    Spinal Cord Diseases
    Hypoxia