Spasticity and Functional Recovery After SCI

Spinal Cord Injuries Clinical Trial

Official title:

Spasticity and Functional Recovery in Humans With Acute to Subacute Spinal Cord Injury.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06030531
• Other study ID #: STU00210582
• Status: Enrolling by invitation
• Start date: July 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Muscle Spasticity
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Measures of spasticity, connectivity and analysis of single nucleotide polymorphisms and biomarkers of inflammation
We will test for presence of biological markers in 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.
• Analysis of biomarkers
We will test for the presence of biological markers in the blood to compare the distribution of polymorphisms and biomarkers with the spinal cord injury patient population.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth scale (MAS)	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)	From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
Primary	Motor evoked potential (MEP)	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.	From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
Primary	First swing test (FST)	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.	From the time of admission to the hospital and enrolled in the study till the time of the discharge (up to 12 weeks)
Secondary	International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)	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	From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
Secondary	Circulating biomarkers of inflammation and neuroplasticity	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-?B) inflammatory pathway. Specifically, we will characterize serum levels of pro-inflammatory cytokines interleukin-1 beta (IL-1ß), interleukin-6 (IL-6), tumor necrosis factor (TNF-a) and anti-inflammatory marker interleukin-10 (IL-10). We will also measure levels of circulating neuroplasticity marker Brain-derived neurotrophic factor (BDNF)	From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)