search
Back to results

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

Primary Purpose

Spinal Cord Injuries, Spinal Cord Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injury, Stimulation, Spinal Stimulation, Noninvasive stimulation, Acute intermittent hypoxia, Hypoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shirley Ryan AbilityLabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Sham Comparator

Arm Label

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

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

Change in 10 Meter Walk Test
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed.
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. This test may be repeated up to 3 times during each assessment visit and during each training visit.

Full Information

First Posted
April 17, 2019
Last Updated
October 24, 2022
Sponsor
Shirley Ryan AbilityLab
Collaborators
University of California, Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT03922802
Brief Title
SCI Acute Intermittent Hypoxia and Non-Invasive Spinal Stimulation Combined With Gait Training
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spinal Cord Diseases
Keywords
Spinal Cord Injury, Stimulation, Spinal Stimulation, Noninvasive stimulation, Acute intermittent hypoxia, Hypoxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Arm Type
Experimental
Arm Description
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
Arm Title
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Other Intervention Name(s)
AIH + tSCS+ Gait
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Other Intervention Name(s)
SHAM AIH + tSCS + Gait
Intervention Description
Subjects will perform locomotor activities with transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
Intervention Type
Other
Intervention Name(s)
Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
Other Intervention Name(s)
SHAM AIH + SHAM tSCS + Gait
Intervention Description
Subjects will perform locomotor activities with sham transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
Primary Outcome Measure Information:
Title
Change in 6 Minute Walk Test
Description
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.
Time Frame
Session 1 (baseline test, initial visit), After 5 intervention sessions (Post Test), 1 week post (1 week follow up Post)
Secondary Outcome Measure Information:
Title
Change in 10 Meter Walk Test
Description
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed.
Time Frame
Session 1 (baseline test, initial visit), After 5 intervention sessions (Post Test), 1 week post (1 week follow up Post)
Title
Timed Up and Go Test: Assesses mobility, balance, walking ability and fall risk
Description
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. This test may be repeated up to 3 times during each assessment visit and during each training visit.
Time Frame
Session 1 (baseline test, initial visit), After 5 intervention sessions (Post Test), 1 week post (1 week follow up Post)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly A McKenzie, PT, DPT, NCS
Phone
312-238-7111
Email
kmckenzie@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun Jayaraman, PT, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly A McKenzie, PT, DPT, NCS
First Name & Middle Initial & Last Name & Degree
Arun Jayaraman, PT, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs