Spasticity and Functional Recovery After SCI

Shirley Ryan AbilityLab

Status: Invitation-only

Conditions: Spinal Cord Injuries; Acute Spinal Cord Injury

Treatments: Other: Measures of spasticity, connectivity and analysis of single nucleotide polymorphisms and biomarkers of inflammation; Other: Analysis of biomarkers

Study type: Observational

Funder types: Other

Identifiers

NCT06030531

STU00210582

Details and patient eligibility

About

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 are not yet understood. Using electrophysiological and imaging techniques along with traditional measurements of neurological recovery in the acute rehabilitation setting including physical exam and functional assessments; the investigators aim to examine the relationship between development of spasticity, residual descending motor pathways and functional and neurological recovery in humans with SCI from acute to subacute phase

Full 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 neurological recovery and functional improvement in individuals with SCI from the acute to the subacute phase. The investigators will also test for the presence of biological markers in the blood that may correlate with levels of spasticity or neurological recovery and functional improvement, including the presence or absence of neuroplastic genetic polymorphisms (e.g. BDNF Val66Met polymorphism), as well as circulating levels of neuroplastic (e.g. BDNF) or inflammatory factors (e.g. interleukins, TNF) that may affect neuronal growth and functional restoration.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

240 participants in 2 patient groups

Inpatients

Description:

Prospective participants who meet the study inclusion criteria will be identified by bi-weekly chart review of all new admissions to the acute inpatient spinal cord injury unit at the Shirley Ryan AbilityLab (SRAlab). Eligible patients will be invited to participate by the clinical staff during their first week of admission.

Treatment:

Other: Analysis of biomarkers

Other: Measures of spasticity, connectivity and analysis of single nucleotide polymorphisms and biomarkers of inflammation

Control group

Description:

We will enroll non-injured healthy individuals to compare the level of biomarkers

Treatment:

Other: Analysis of biomarkers