A Multicenter Clinical Trial to Evaluate the Effectiveness of Intermittent Hypoxia Therapy in Individual With Spinal Cord Injury



Status:Recruiting
Conditions:Hospital, Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - 70
Updated:9/20/2018
Start Date:August 22, 2018
End Date:July 2022
Contact:Kiara Melendez, BS, MPH
Email:kcm26@med.miami.edu
Phone:3052439301

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A Multi-Center Clinical Trial to Evaluate the Effectiveness of Intermittent Hypoxia Therapy in Individuals With Spinal Cord Injury

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).


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.
We found this trial at
1
site
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Monica A Perez, PhD
Phone: 305-243-9301
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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