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

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03922802
• Other study ID #: STU00211806
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Shirley Ryan AbilityLab
• Contact: Kelly A McKenzie, PT, DPT, NCS
• Phone: 312-238-7111
• Email: kmckenzie[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Spinal Cord Diseases
• Spinal Cord Injuries

Intervention

Device:
• Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + 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.

Other:
• Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
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 Training
Subjects will perform locomotor activities with sham transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Session 1 (baseline test, initial visit), After 5 intervention sessions (Post Test), 1 week post (1 week follow up Post)
Secondary	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.	Session 1 (baseline test, initial visit), After 5 intervention sessions (Post Test), 1 week post (1 week follow up Post)
Secondary	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.	Session 1 (baseline test, initial visit), After 5 intervention sessions (Post Test), 1 week post (1 week follow up Post)