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

NCT05589402 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB-18-0596
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Spine Disease; Stroke

Keywords

Rehabilitation; Numbing; temporary deafferentation-induced cortical plasticity

Outcome Measures

Primary Outcomes (2)

• Electromyography (EMG)

  The investigators will use an electrical stimulator to send an electrical signal to a target muscle to initiate contraction, and an Electromyography (EMG) will be used to record the changes in target muscle response from baseline, pre-test, and post-test. An electronic nerve stimulator will output a pulse ranging from 0 mV to 2 mV for an appropriate maximum muscle contraction to occur, and an Electromyography (EMG in root mean square) will capture the muscle's contraction via surface electrodes. A greater number of Root Mean Square (RMS) millivoltage registered on the EMG signifies a higher response from the muscle, additionally, any plateau of the RMS while administering higher mV from the Stimulator will signify a maximum contraction of the muscle.

  Throughout Study Duration, an average of four weeks

• Transcranial Magnetic Stimulation (TMS)

  Using Transcranial Magnetic Stimulation (TMS) to promote Motor Evoked Potentials (MEP), the Investigators will monitor changes in cortical excitability of the target muscle's motor hotspot by measuring the muscle excitability with Electromyography (EMG; in millivolts) from Baseline, Pre-test, and at Post-test. The motor hotspot of the weak muscle will be defined as the site that evokes MEPs ≥50 mV at the lowest intensity (% device output), or the resting motor threshold (RMT). A decrease of the TMS's percentage output to promote MEPs of the weak muscle signifies a decrease in the cortical excitability, as measured by Active Motor Thresholds (AMT) and Active Motor Evoked Potentials (AMEP).

  Throughout Study Duration, an average of four weeks

Study Arms (2)

Lidocaine Cream 5%

EXPERIMENTAL

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.

Drug: Lidocaine Cream 5%

Rehabilitation Movement Training

OTHER

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.

Other: Rehabilitation Movement Training

Interventions

Lidocaine Cream 5% DRUG

Ebanel 5% Lidocaine Topical Numbing Cream Maximum Strength 1.35 Oz, Numb520 Pain Relief Cream Anesthetic Cream Infused with Aloe Vera, Vitamin E, Lecithin, Allantoin, Secured with Child Resistant Cap

Also known as: Ebanel, UBER NUMB

Lidocaine Cream 5%

Rehabilitation Movement Training OTHER

reaching tasks, hand exercises (e.g., putty, grip exerciser, resistance bands, etc).

Rehabilitation Movement Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Rio Grande Valley: lead

Study Sites (1)

University of Texas Rio Grande Valley

Harlingen, Texas, 78550, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Diseases; Stroke

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Bone Diseases; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kelsey Baker

  University of Texas Rio Grande Valley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: October 21, 2022
• Study Start: June 4, 2019
• Primary Completion (Estimated): June 4, 2026
• Study Completion (Estimated): June 4, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)