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

Launched by SHIRLEY RYAN ABILITYLAB · Apr 17, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for people who have suffered spinal cord injuries. Specifically, it combines two therapies: acute intermittent hypoxia therapy (which involves short periods of reduced oxygen) and non-invasive spinal cord stimulation, alongside gait training. The goal is to see if this combination can help improve walking and balance for individuals with spinal cord injuries.

To be eligible for the trial, participants need to be at least 18 years old, have a spinal cord injury below the neck (C2), and have been injured for at least six months. They should not be receiving regular physical therapy or be on certain medications that might interfere with the study. Participants will be closely monitored during the trial and will have the opportunity to contribute to research that could lead to better rehabilitation options for spinal cord injuries. If you or someone you know fits these criteria and is interested in participating, it could be a valuable opportunity to explore new treatment options.

Gender

ALL

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