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

Status: Recruiting

Location: See location...

Intervention Type: Other, Drug

Study Type: Interventional

Study Phase: Phase 1

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 75

Healthy Volunteers: t

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⁃ 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

Locations

United States

Texas

University of Texas Rio Grande Valley

RECRUITING

Harlingen

Contact Information

Primary

Daniel Salinas, BS

daniel.salinas02@utrgv.edu

9562962014

Backup

Kelsey Baker

kelsey.baker@utrgv.edu

9562961337

Time Frame

Start Date: 2019-06-04

Estimated Completion Date: 2026-06-04

Participants

Target number of participants: 30

Treatments

Experimental: Lidocaine Cream 5%

A topical anesthetic will be used to deliver temporary inactivation of muscle sensation. Specifically, due to its high safety profile, Lidocaine Cream 5% will be used in the current sub-study. Lidocaine cream (5%) is FDA-approved and available over-the-counter. The investigators will apply the lidocaine cream 5% following FDA guidelines and previously published protocol methodology. A test will be utilized to evaluate if the approach provides complete and temporary inactivation of sensation from the biceps. The von Frey filament test will be used with filaments ranging in size (1,65 to 6,65) to be placed on the biceps muscle every 15 minutes after lidocaine application.~Based on published work, and the current investigators' pilot data, it is anticipated that all sensations from the biceps should be blocked approximately 30 to 60 minutes after lidocaine application. Complete temporary inactivation will be defined at the point when all baseline sensation can no longer be achieved.

Other: Rehabilitation Movement Training

During temporary deafferentation, subjects will perform movement training. Similar to other single-session studies, the current investigators chose to pair the paradigm with movement training to bolster the effects of the approach.~A reaching task that is commonly performed in rehabilitation will be used. Task practice will be performed for 1 hour, with breaks given every 10 minutes. Past experiments in the current investigators' lab have adopted a similar protocol for task practice in SCI and found no adverse events. Movement training will also be assisted by the Bionik InMotion Arm/Hand robot, which has been studied in clinical and rehabilitative practices for over 20 years.~Movement training at 1 hour will be ceased due to issues with fatigue, as has been noted in previous SCI clinical studies. In addition, published work suggests that lidocaine has a half-life of one 1 hour. Thus, maximum benefits should be achieved at the 1-hour mark after application.

Related Therapeutic Areas

Stroke

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

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