Clinical trial NCT06030531: Spasticity and Functional Recovery After SCI
Official title: Spasticity and Functional Recovery in Humans With Acute to Subacute Spinal Cord Injury.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Spinal Cord Injury
Spinal Cord Injuries
Keywords: Spasticity
Recovery
Bio-markers
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Modified Ashworth scale (MAS)
timeFrame: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
measure: Motor evoked potential (MEP)
timeFrame: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
measure: First swing test (FST)
timeFrame: 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:
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
timeFrame: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
measure: Circulating biomarkers of inflammation and neuroplasticity
timeFrame: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Monica A Perez, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: