Spasticity and Functional Recovery After SCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Acute Spinal Cord Injury Spinal Cord Injuries

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type 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.

Analysis of biomarkers

Intervention Type 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

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

Analysis of biomarkers

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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

1. Male and females 18 years of age or greater
2. Basic proficiency in English language communication

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:

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes