RECRUITING

Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI

Conditions

Spinal Cord Injuries Spine Disease Stroke Rehabilitation Numbing temporary deafferentation-induced cortical plasticity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators are conducting a research study to try to improve rehabilitation interventions for individuals with spinal cord injury (SCI). In this study, the aim is to determine if temporarily numbing non-paralyzed arm muscles with an over-the-counter numbing cream while exercising paralyzed muscles, can improve the strength, function, and sensation of paralyzed muscles after a spinal cord injury.

Official Title

Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI

Quick Facts

Study Start:2019-06-04

Study Completion:2025-06-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05589402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged between 18 and 75 years old * Have physician diagnosed cervical incomplete spinal cord injury or lesion (iSCI) * Classified by the American Spinal Cord Association (AIS) impairment scale as AIS C or D * iSCI occurred at least 18 months ago * Level of injury or lesion is between C2 and T1 * Bicep strength must be classified as ≥ 3 muscle grade as defined by the medical research council scale * Tricep strength must be at least an MRC grade of 2 and bet at least 1 muscle grade lower than the bicep * Both the biceps and triceps will be required to elicit an active motor evoked potential \>200 uV with transcranial magnetic stimulation * Must maintain current medication regime * Must present with a weaker side of the body, as indicated by a Upper extremity motor score difference between the left and right side * UEMS \< 40 (50 max score) * Must be able to perform reaching movement training task * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged between 18 and 75 years old * Must be right-handed * Must be able to perform hand exercises	* Pacemaker or another implanted device * Metal in the skull * History of seizures * Pregnancy * First-degree relative with medication-resistant epilepsy * Current participation in upper limb rehabilitation therapies * Current use of illicit drugs, abusing alcohol, or have withdrawn from alcohol in the last 6 months * Other neurological impairment or condition * Pressure ulcers * Significant lower motor neuron loss at C7 as noted by a nerve conduction velocity \<50 m/s * History of traumatic brain injury as documented by Rancho Scale Impairment of \<5 * History of brain MRI documented focal cerebral cortex infarct (e.g. hydrocephalus) * Contractures at the elbow * Severe spasticity as noted by a modified ashworth scale (MAS) \> 4 * Documented, non-sedated post-traumatic amnesia lasting more than 48 hours * Pregnancy * Allergic to lidocaine * A neuroactive medication that has the potential to lower the seizure threshold * Based on documented publications in stroke, this will include bupropion (wellbutrin), psychostimulants and neuroleptics * All medications will be reviewed with physician, Dr. Amol Utturkar (DHR) * Pacemaker or other implanted device * Metal in the skull * History of seizures * First-degree relative with medication-resistant epilepsy * Current use of illicit drugs (including heroin, crack/cocaine, marijuana), abusing alcohol or having withdrawn from alcohol in the last 6 months * Allergy to lidocaine * Other neurological impairment or condition * Pregnancy * A neuroactive medication that has the potential to lower the seizure threshold * Based on documented publications on stroke, this will include bupropion (wellbutrin), psychostimulants and neuroleptics

Inclusion Criteria

Exclusion Criteria

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged between 18 and 75 years old
* Have physician diagnosed cervical incomplete spinal cord injury or lesion (iSCI)
* Classified by the American Spinal Cord Association (AIS) impairment scale as AIS C or D
* iSCI occurred at least 18 months ago
* Level of injury or lesion is between C2 and T1
* Bicep strength must be classified as ≥ 3 muscle grade as defined by the medical research council scale
* Tricep strength must be at least an MRC grade of 2 and bet at least 1 muscle grade lower than the bicep
* Both the biceps and triceps will be required to elicit an active motor evoked potential \>200 uV with transcranial magnetic stimulation
* Must maintain current medication regime
* Must present with a weaker side of the body, as indicated by a Upper extremity motor score difference between the left and right side
* UEMS \< 40 (50 max score)
* Must be able to perform reaching movement training task
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged between 18 and 75 years old
* Must be right-handed
* Must be able to perform hand exercises

* Pacemaker or another implanted device
* Metal in the skull
* History of seizures
* Pregnancy
* First-degree relative with medication-resistant epilepsy
* Current participation in upper limb rehabilitation therapies
* Current use of illicit drugs, abusing alcohol, or have withdrawn from alcohol in the last 6 months
* Other neurological impairment or condition
* Pressure ulcers
* Significant lower motor neuron loss at C7 as noted by a nerve conduction velocity \<50 m/s
* History of traumatic brain injury as documented by Rancho Scale Impairment of \<5
* History of brain MRI documented focal cerebral cortex infarct (e.g. hydrocephalus)
* Contractures at the elbow
* Severe spasticity as noted by a modified ashworth scale (MAS) \> 4
* Documented, non-sedated post-traumatic amnesia lasting more than 48 hours
* Pregnancy
* Allergic to lidocaine
* A neuroactive medication that has the potential to lower the seizure threshold
* Based on documented publications in stroke, this will include bupropion (wellbutrin), psychostimulants and neuroleptics
* All medications will be reviewed with physician, Dr. Amol Utturkar (DHR)
* Pacemaker or other implanted device
* Metal in the skull
* History of seizures
* First-degree relative with medication-resistant epilepsy
* Current use of illicit drugs (including heroin, crack/cocaine, marijuana), abusing alcohol or having withdrawn from alcohol in the last 6 months
* Allergy to lidocaine
* Other neurological impairment or condition
* Pregnancy
* A neuroactive medication that has the potential to lower the seizure threshold
* Based on documented publications on stroke, this will include bupropion (wellbutrin), psychostimulants and neuroleptics

Contacts and Locations

Study Contact

Daniel Salinas, BS

CONTACT

9562962014

daniel.salinas02@utrgv.edu

Kelsey Baker

CONTACT

9562961337

kelsey.baker@utrgv.edu

Principal Investigator

Kelsey Baker

PRINCIPAL_INVESTIGATOR

University of Texas Rio Grande Valley

Study Locations (Sites)

University of Texas Rio Grande Valley

Harlingen, Texas, 78550

United States

Collaborators and Investigators

Sponsor: University of Texas Rio Grande Valley

Kelsey Baker, PRINCIPAL_INVESTIGATOR, University of Texas Rio Grande Valley

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-04

Study Completion Date2025-06-04

Study Record Updates

Study Start Date2019-06-04

Study Completion Date2025-06-04

Terms related to this study

Keywords Provided by Researchers

Rehabilitation
Numbing
temporary deafferentation-induced cortical plasticity

Additional Relevant MeSH Terms

Spinal Cord Injuries
Spine Disease
Stroke