Clinical trial NCT03644277: A Multi-Center Clinical Trial in Individuals with Spinal Cord Injury
Official title: HANDS: a Multi-Center Clinical Trial to Evaluate the Effectiveness of Intermittent Hypoxia Therapy in Individuals with Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of this project is to investigate the effectiveness of daily acute intermittent hypoxia therapy (dAIH), coupled with massed practice training, to improve upper-extremity function in individuals with chronic incomplete cervical SCI.

Detailed description: Specific Aim 1: Evaluate the effectiveness of a combined intervention utilizing dAIH and massed practice upper extremity training on arm and hand function in individuals with incomplete tetraplegia.

Specific Aim 2: Evaluate the effectiveness of a combined intervention utilizing dAIH therapy and robotic rehabilitation device-administered upper-extremity training on arm and hand function in persons with incomplete tetraplegia.

Eligibility criteria: Inclusion:

1. History of a non-progressive spinal cord injury, at or below C2, and at or above T1.
2. Between the ages of 18 - 75 years.
3. Time since injury must be at least 6 months if the injury was traumatic in nature. If the spinal cord injury is non-traumatic, participants must meet at least the initial 6-month criteria in addition to either no regression in symptoms for at least two years, per self-report or per medical monitor discretion.
4. Demonstrate voluntary motor activation in hand muscles, with a score of at least a 2 on at least one of the Prehension Ability grasp patterns of the GRASSP assessment (cylindrical grasp, lateral key pinch, and tip to tip pinch), on at least one upper extremity.
5. Ability to understand and the willingness to sign an informed consent.
6. At least a 10% change in isometric elbow strength above baseline, after a single bout of Acute Intermittent Hypoxia (AIH), during screening.

Exclusion:

1. 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.
2. Women who are currently pregnant/nursing or planning on becoming pregnant.
3. Individuals with a tracheostomy or who utilize mechanical ventilation.
4. Individuals who are currently enrolled in another interventional research study or in therapy related to upper extremity function.
5. Participants will be excluded if they have had a botulinum toxin injection to upper extremity musculature within the last 3 months. Participants will need to refrain from upper 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.
6. Documented sleep apnea.
7. Orthopedic injuries or surgeries that would impact an individual's ability to use the upper extremity.
8. Traumatic brain injury or other neurological conditions that would impact the study.
9. Blood hemoglobin levels less than 10g/dL.

Primary outcomes:
measure: GRASSP
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: