Status:
UNKNOWN
Spasticity and Functional Recovery After SCI
Lead Sponsor:
Shirley Ryan AbilityLab
Conditions:
Acute Spinal Cord Injury
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Brief Summary
Spasticity is one of the most common symptoms manifested in humans with spinal cord injury (SCI). However, the neural mechanisms underlying the development of spasticity over time after an acute SCI a...
Detailed Description
The purpose of this study is to measure changes to motor-evoked potentials (MEPs) and to evaluate if the development of spasticity is related to residual descending motor pathways and to a better neur...
Eligibility Criteria
Inclusion
- Individuals with SCI:
- Inclusion criteria:
- Male and females 18 years of age or greater
- Basic proficiency in English language communication
- Are admitted to the Shirley Ryan AbilityLab as a spinal cord injury patient
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) level above L2
- American Spinal Cord Injury Association Impairment Scale (AIS) grades A, B, C, or D
- Patients with SCI within the first week of inpatient admission to the Shirley Ryan AbilityLab after sustaining a SC
- Exclusion criteria:
- Under 18 years of age
- Severe cognitive impairment that precludes the ability to participate in a comprehensive physical exam or give verbal consent
- ISNCSCI level below L2
- People who have sustained SCI \>30 days
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
- 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
- Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
- History of seizures or epilepsy
- Ongoing cord compression or a syrinx in the spinal cord or people who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk 13. Metal plate in skull
- Individuals with scalp shrapnel, cochlear implants, or aneurysm clips
- Skull fractures, skull deficits or concussion within the last 6 months
- Presence of orthoses and presence of spinal precautions or healing incisions that make the area inaccessible to the testing procedures. This criterion will be applied as needed for the specific study procedures that may need to access the areas under restriction.
- Formal diagnosis of Post-Traumatic Stress Disorder (PTSD)
- Individuals in the control group:
- Inclusion criteria:
- Male and females 18 years of age or greater
- Basic proficiency in English language communication
- Exclusion criteria:
- Under 18 years of age
- Uncontrolled medical problems including pulmonary, cardiovascular, or orthopedic disease
- History of neurological impairment or conditions affecting the Central Nervous System
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- Pregnancy
Exclusion
Key Trial Info
Start Date :
July 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06030531
Start Date
July 1 2020
End Date
December 31 2024
Last Update
September 11 2023
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611