Last updated: May 21, 2021
Sponsor: Shirley Ryan AbilityLab
Overall Status: Active - Recruiting
Phase
N/A
Condition
Spinal Cord Injuries
Treatment
N/AClinical Study ID
NCT03598504
STU00209996
1R01NS100810-01A1
Ages 18-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male and females between ages 18-85 years of age
- SCI ( ≥1 month of injury)
- ASIA A, B,C and D
- SCI above L5
- Able to perform a visible contraction with dorsiflexor and hip flexor muscles (allowing testing of largely impaired patients)
- Able to ambulate a few steps with or without an assistive device. Inclusion criteria for healthy controls:
- Male and females between ages 18-85 years
- Able to complete precision grips with both hands
- Able to complete full elbow flexion-extension with both arms.
- Able to walk and complete lower-limb tests with both legs.
Exclusion
Exclusion Criteria:
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedicdisease,
- Any debilitating disease prior to the SCI that caused exercise intolerance
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- History of head injury or stroke,
- Metal plate in skull
- History of seizures
- Receiving drugs acting primarily on the central nervous system, which lower theseizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclicantidepressants.
- Pregnant females, and
- Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinalcord disease such as spinal stenosis, spina bifida or herniated cervical disk. This information will be obtained by self-report.
Study Design
Total Participants: 198
Study Start date:
July 16, 2019
Estimated Completion Date:
June 30, 2023
Study Description
Connect with a study center
University of Miami The Miami Project to Cure Paralysis
Miami, Florida 33136
United StatesSite Not Available
Shirley Ryan AbilityLab
Chicago, Illinois 60611
United StatesActive - Recruiting
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