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

• Status: Recruiting
• Trial end date: 2024-06-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Rio Grande Valley
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

SCI Patients:

• 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

Healthy Controls:

• 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

Exclusion Criteria:

SCI Patients:

• 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)

Healthy Controls:

• 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