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Rehabilitation Training + Lidocaine for Spinal Cord Injury

Phase 1
Recruiting
Led By Kelsey Baker
Research Sponsored by University of Texas Rio Grande Valley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study duration, an average of four weeks
Awards & highlights

Study Summary

This trial seeks to improve SCI rehabilitation by numbing non-paralyzed arm muscles while exercising paralyzed muscles to increase strength, function, and sensation.

Who is the study for?
This trial is for adults aged 18-75 with cervical incomplete spinal cord injury (iSCI) classified as AIS C or D, at least 18 months post-injury. Participants must have certain levels of bicep and tricep strength, a weaker side of the body, and be able to do reaching exercises. Exclusions include other neurological conditions, metal in the skull, seizure history, pregnancy, lidocaine allergy, severe spasticity or motor neuron loss.Check my eligibility
What is being tested?
The study tests if using Lidocaine cream to numb non-paralyzed arm muscles can enhance rehabilitation outcomes for paralyzed muscles in SCI patients during movement training exercises. The goal is to improve muscle strength and function by focusing on exercising the paralyzed limbs without interference from stronger muscles.See study design
What are the potential side effects?
Potential side effects may include temporary skin irritation or allergic reactions where the Lidocaine cream is applied. Since it's a topical numbing agent used over-the-counter for minor pain relief, serious side effects are uncommon but could involve unusual sensations like tingling or numbness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study duration, an average of four weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study duration, an average of four weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Electromyography
Transcranial Magnetic Stimulation (TMS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Rehabilitation Movement TrainingExperimental Treatment1 Intervention
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.
Group II: Lidocaine Cream 5%Experimental Treatment1 Intervention
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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Texas Rio Grande ValleyLead Sponsor
6 Previous Clinical Trials
2,595 Total Patients Enrolled
Kelsey BakerPrincipal InvestigatorUniversity of Texas Rio Grande Valley

Media Library

Rehabilitation Movement Training Clinical Trial Eligibility Overview. Trial Name: NCT05589402 — Phase 1
Spinal Cord Injury Research Study Groups: Rehabilitation Movement Training, Lidocaine Cream 5%
Spinal Cord Injury Clinical Trial 2023: Rehabilitation Movement Training Highlights & Side Effects. Trial Name: NCT05589402 — Phase 1
Rehabilitation Movement Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05589402 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a governmental sanction for Lidocaine Cream 5% to be utilized?

"Given the limited amount of data surrounding its efficacy and safety, Lidocaine Cream 5% was assigned a score of 1."

Answered by AI

Am I a suitable candidate for this research project?

"Per the eligibility criteria, eligible patients must have suffered a stroke and fall within 18-75 years of age. This study has an expected enrollment of nearly 30 participants."

Answered by AI

What is the current number of participants for this trial?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this medical investigation, which was originally posted on June 4th 2019, is still enrolling participants. Approximately 30 patients are needed to be recruited from 1 healthcare centre."

Answered by AI

Does the trial accept participants of all ages, or is a certain age bracket required?

"This study is open to adults aged between 18 and 75."

Answered by AI

Are participants still being sought for this investigation?

"The study, initially posted on June 4th 2019 and most recently amended on October 17th 2022, is currently searching for patients per the information provided by clinicaltrials.gov."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI
2019. "Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05589402.
~0 spots leftby Jun 2024
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