Spasticity and Functional Recovery After SCI

Launched by SHIRLEY RYAN ABILITYLAB · Sep 1, 2023

Keywords

ClinConnect Summary

This is an observational study at the Shirley Ryan AbilityLab that looks at adults with an acute spinal cord injury to understand how muscle stiffness (spasticity) develops in the first weeks after injury and how it relates to remaining nerve pathways and overall recovery. Doctors will assess spasticity with a standard scale, test how well brain signals reach leg muscles using motor-evoked potentials from brain stimulation, and use a knee-swing test to gauge tone. They will also measure blood markers of inflammation and nerve growth (including BDNF) and check a common genetic variant that might affect recovery. A healthy, non-injured control group will be used for comparison.

Who can join: adults 18 and older with a spinal cord injury admitted to SRAlab within the first week of injury, with injury levels above the lower part of the spine (ISNCSCI level above L2) and AIS grades A–D. About 240 participants are planned. The study does not test a treatment; instead it collects measurements during the hospital stay (up to about 12 weeks). Healthy volunteers will be enrolled as controls for the biomarker comparisons. Some blood samples may be stored for future approved research if participants consent. The study is currently enrolling by invitation.

Gender

ALL

Eligibility criteria

• 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:
• • 1. Male and females 18 years of age or greater
• • 2. Basic proficiency in English language communication
• Exclusion criteria:
• • 1. Under 18 years of age
• • 2. Uncontrolled medical problems including pulmonary, cardiovascular, or orthopedic disease
• • 3. History of neurological impairment or conditions affecting the Central Nervous System
• • 4. Premorbid, ongoing major depression or psychosis, altered cognitive status
• • 5. Pregnancy