Status:
UNKNOWN
Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI
Lead Sponsor:
Shirley Ryan AbilityLab
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will utilize short duration and mild levels of reduced oxygen (hypoxia) to induce spinal plasticity while evaluating the appropriate timing schedule for this intervention, as well as, the e...
Eligibility Criteria
Inclusion
- Spinal cord lesion at level of C3 to T1
- Individuals with a history of incomplete spinal cord injury, classified as ASIA C or D
- Individuals must be at least 6 months status post injury
- Individuals must be between the ages of 18-70 years inclusive, male or female
- Spinal cord injury must be secondary to a non-progressive etiology
- Individuals must be medically stable.
- Able to comply with protocol/study requirements
- Not currently (\>2 weeks) taking any medications for spasticity management.
Exclusion
- Recent change in the use of narcotic, anti-inflammatory or pain medication
- Unstable medical conditions or any other clinical observation that may affect the candidate's performance, health, safety or the ability to participate in the study, as determined by the treating therapist
- History of sleep apnea
- Active participation in another movement research study or therapy program
- Anti-spasticity drug injection less than 3 months, prior to beginning treatment
- Musculoskeletal pain that interferes with participation in study
- Women who are currently, may be or planning on becoming pregnant
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03774043
Start Date
May 1 2016
End Date
July 1 2020
Last Update
February 19 2020
Active Locations (1)
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1
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611