Hines, Illinois 60141

  • Spinal Cord Injuries

Purpose:

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 spinal cord injury (SCI).


Criteria:

Inclusion Criteria: - History of motor incomplete spinal cord injury (AISA C and D) at or below C3, and at or above T1 from a non-progressive etiology. - Between the ages of 18 - 70 years. - At least 6 months since onset of spinal cord injury. - Ability to close and open at least one hand without assistance, without significant use of tenodesis. - Ability to understand and the willingness to sign an informed consent. - Not currently (>2 weeks) taking any medications for spasticity management. - At least a 10% change in isometric elbow strength above baseline, after a single bout of Acute Intermittent Hypoxia (AIH), during screening (described below in detail). Exclusion Criteria: - 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. - Women who are currently pregnant/nursing or planning on becoming pregnant. - individuals with a tracheostomy or who utilize mechanical ventilation. - Individuals who are currently enrolled in another interventional research study or in therapy. A medical clearance will be required if patients are taking any other investigational agents. - Individuals who have an intrathecal baclofen pump or currently taking anti-spasticity medications. These medications include: Baclofen (Lioresal), Clonazepam (Klonopin), Dantrolene (Dantrium), Diazepam (Valium), or Trizanidine (Zanaflex). Subjects will be allowed to participate in the study if they agree to wean off of these medications. - Documented obstructive sleep apnea. - Orthopedic injuries or surgeries that would impact an individual's ability to use the upper extremity. - Traumatic brain injury or other neurological conditions.


NCT ID:

NCT03433599


Primary Contact:

Principal Investigator
Monica A Perez, PhD
Shirley Ryan AbilityLab

Monica Perez, PhD
Phone: 312-238-2886
Email: mperez04@sralab.org


Backup Contact:

N/A


Location Contact:

Hines, Illinois 60141
United States

Monica Perez, PhD, PT
Phone: 312-238-2443
Email: mperez04@sralab.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 18, 2021

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