Spasticity and Functional Recovery After SCI

• Conditions: Acute Spinal Cord Injury; Spinal Cord Injuries
• Interventions: Other: Measures of spasticity, connectivity and analysis of single nucleotide polymorphisms and biomarkers of inflammation; Other: Analysis of biomarkers

• Registration Number: NCT06030531
• Lead Sponsor: Shirley Ryan AbilityLab

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 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

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 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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2022-04-07
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inpatients	Measures of spasticity, connectivity and analysis of single nucleotide polymorphisms and biomarkers of inflammation	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.
Inpatients	Analysis of biomarkers	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.
Control group	Analysis of biomarkers	We will enroll non-injured healthy individuals to compare the level of biomarkers

Primary Outcome Measures

Name	Time	Method
Modified Ashworth scale (MAS)	From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)	This clinical scale will be used by measuring resistance encountered during manual passive muscle stretching using a six-point ordinal scale (0=no increase in tone, 1/+1=slight increase in tone with a catch and release or minimal resistance at the end or less than half of the range of movement, respectively, 2=more marked increased tone through most of the range of movement but affected parts easily moved, 3=considerable increase in tone and passive movement difficultly, and 4=affected parts rigid)
Motor evoked potential (MEP)	From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)	Transcranial magnetic stimulation will be delivered and the coil will be positioned over the vertex and moved around this point to determine the optimal position for eliciting a motor evoked potentials (MEPs) in legs muscles.
First swing test (FST)	From the time of admission to the hospital and enrolled in the study till the time of the discharge (up to 12 weeks)	We will use the pendulum test to measure muscle tone at the knee by using gravity to provoke muscle stretch reflexes during passive swinging of the lower limb.

Secondary Outcome Measures

Name	Time	Method
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)	From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)	At the time of the admission, after obtaining consent, and at the time of discharge, the chart will be reviewed to obtain the ISNCSCI score
Circulating biomarkers of inflammation and neuroplasticity	From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)	In this study, we will focus on tracking expression of key inflammatory cytokines that have been shown to play a pivotal role in activating the major nuclear factor kappa-B (NF-κB) inflammatory pathway. Specifically, we will characterize serum levels of pro-inflammatory cytokines interleukin-1 beta (IL-1β), interleukin-6 (IL-6), tumor necrosis factor (TNF-α) and anti-inflammatory marker interleukin-10 (IL-10). We will also measure levels of circulating neuroplasticity marker Brain-derived neurotrophic factor (BDNF)

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States