Clinical trial NCT03922802: 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
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Keywords: Spinal Cord Injury
Stimulation
Spinal Stimulation
Noninvasive stimulation
Acute intermittent hypoxia
Hypoxia
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2019-04-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in 6 Minute Walk Test
timeFrame: Session 1 (baseline test, initial visit), After 5 intervention sessions (Post Test), 1 week post (1 week follow up Post)
Secondary outcomes:
measure: Change in 10 Meter Walk Test
timeFrame: Session 1 (baseline test, initial visit), After 5 intervention sessions (Post Test), 1 week post (1 week follow up Post)
measure: Timed Up and Go Test: Assesses mobility, balance, walking ability and fall risk
timeFrame: Session 1 (baseline test, initial visit), After 5 intervention sessions (Post Test), 1 week post (1 week follow up Post)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: