Spasticity and Functional Recovery After SCI

NCT06030531 | Unknown

• 1 other identifier: STU00210582
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Spinal Cord Injury; Spinal Cord Injuries

Keywords

Spasticity; Recovery; Bio-markers

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (2)

• 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)

• 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)

Study Arms (2)

Inpatients

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.

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

Control group

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

Other: Analysis of biomarkers

Interventions

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

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.

Inpatients

Analysis of biomarkers OTHER

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.

Control group; Inpatients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective participants who meet the study inclusion criteria will be identified by bi-weekly chart review ofall 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. Prospective participants that meet the inclusion criteria for the Control group will be recruited using various sources including the Shirley Ryan AbilityLab non-patient research database, participants who have taken part in our earlier studies, word of mouth, people who work at or visit our center and are interested in research participation.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

De-identified plasma and DNA extracts will be stored in key-lock secured -80 oC freezers in the Biologics Lab at SRALab until used for experimental purposes. Subjects will have the choice to allow researchers approved by this IRB to retain any leftover plasma or DNA extract taken during the study. These samples will be stored indefinitely and may be used only for IRB-approved research by IRB-approved researchers and personnel.

MeSH Terms

Conditions

Spinal Cord Injuries; Muscle Spasticity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Monica A Perez, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: September 11, 2023
• Study Start: July 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

US (1)