Rehabilitation Training + Lidocaine for Spinal Cord Injury

Overseen By Kelsey Baker

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Texas Rio Grande Valley

Must not be taking: Bupropion, Psychostimulants, Neuroleptics

Disqualifiers: Seizures, Pregnancy, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 hour per session

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for individuals with spinal cord injuries, aiming to improve the strength and sensation of paralyzed muscles. The study applies a common numbing cream, lidocaine (Lidocaine Cream 5%), to non-paralyzed arm muscles while exercising the paralyzed ones to determine if this enhances recovery. Ideal candidates have experienced a spinal cord injury affecting the neck or upper back for at least 18 months and have muscle weakness on one side of the body. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to explore this innovative approach.

Do I have to stop taking my current medications for the trial?

No, you must maintain your current medication regime to participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lidocaine cream, particularly at a 5% concentration, is generally safe for skin application. The FDA has approved it as an over-the-counter product for temporary numbing. People use it to temporarily lose feeling in specific areas during certain medical procedures. Most users experience only minor side effects, such as slight redness or irritation, while serious side effects are rare.

Studies have also demonstrated that rehabilitation movement training for spinal cord injuries is safe. Past experiments with similar exercises reported no major issues. This type of training has been used in various studies and often improves movement without causing harm.

In summary, both lidocaine cream and movement training have good safety records. They are generally well-tolerated and have been used in different settings without significant problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for spinal cord injury focus on long-term rehabilitation and managing symptoms, but this combination of lidocaine cream and rehabilitation training offers a fresh approach. Lidocaine cream is a topical anesthetic that temporarily inactivates muscle sensation, which can help reset how the brain and muscles interact. This unique mechanism could enhance the effectiveness of movement training, as the temporary sensation block allows the nervous system to relearn movement patterns more effectively. Researchers are excited because the combination of temporary sensory inactivation and robotic-aided movement training could offer faster results and potentially improve the outcomes of rehabilitation for spinal cord injury patients.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

In this trial, participants will receive either Lidocaine Cream 5% or engage in Rehabilitation Movement Training. Research has shown that lidocaine cream, commonly used to numb the skin, can reduce pain for people with spinal cord injuries. In some studies, patients experienced a 45% decrease in pain, with relief lasting up to a year. This suggests that lidocaine might temporarily block sensation in specific muscles, facilitating focus on rehabilitation exercises.

Studies have also found that rehabilitation exercises are crucial for recovery after a spinal cord injury. Exercise can improve strength, function, and sensation. High-intensity and comprehensive rehabilitation programs have led to significant improvements in patient recovery. Using lidocaine alongside movement training could enhance recovery for those with spinal cord injuries. ^{6 7 8 9 10}

Who Is on the Research Team?

Kelsey Baker, PhD

Principal Investigator

University of Texas Rio Grande Valley

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

One side of my body is weaker than the other, as shown by arm strength tests.

My spinal cord injury is moderate to severe but not complete.

Must be right-handed

Exclusion Criteria

I am currently in therapy for my arm or hand.

I have a history of seizures.

I have a close family member with epilepsy that doesn't respond well to medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive temporary inactivation of muscle sensation using Lidocaine Cream 5% and perform movement training with the Bionik InMotion Arm/Hand robot

1 hour per session

Single session

Follow-up

Participants are monitored for changes in cortical excitability and muscle response using TMS and EMG

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine Cream 5%

Trial Overview

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.

How Is the Trial Designed?

Group I: Rehabilitation Movement Training Experimental Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

University of Texas Rio Grande Valley

Lead Sponsor

Trials

8

Recruited

2,700+

Published Research Related to This Trial

In a study using a spinal cord contusion injury model, administering lidocaine shortly after injury significantly reduced harmful cellular effects and improved recovery outcomes, unlike morphine which had no beneficial impact.

Rats treated with lidocaine showed better locomotor recovery, less weight loss, and reduced tissue damage compared to those that experienced noxious stimulation, highlighting the potential of lidocaine in managing pain and promoting healing after spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Input Impairs Recovery after Spinal Cord Injury: Treatment with Lidocaine. Turtle, JD., Strain, MM., Aceves, M., et al.[2022]

In a study of 10 patients with neuropathic pain following spinal cord injury, ketamine demonstrated a significant analgesic effect, with 5 out of 10 patients experiencing at least a 50% reduction in pain, while lidocaine showed minimal effectiveness.

Neither ketamine nor lidocaine altered sensory function or temperature thresholds, indicating that the pain relief from ketamine was not linked to changes in sensory perception, although both treatments were associated with frequent side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The analgesic effect of intravenous ketamine and lidocaine on pain after spinal cord injury. Kvarnström, A., Karlsten, R., Quiding, H., et al.[2022]

In a study involving young male Sprague-Dawley rats, intraparenchymal injection of 0.5% lidocaine into the cervical spinal cord did not cause neuronal damage or inflammation, suggesting it may have a safe profile for local treatment.

The 0.5% lidocaine concentration is proposed to have potential anti-inflammatory effects following spinal cord injury, making it a promising candidate for treating neurodegenerative disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Intraparenchymal Injection of Lidocaine in the Rat Cervical Spinal Cord. Sisti, MS., Zanuzzi, CN., Nishida, F., et al.[2018]

In a study on cats with acute spinal cord trauma, continuous infusion of lidocaine did not improve the generation or conduction of spinal evoked responses, indicating it was ineffective in restoring spinal cord function after injury.

Both lidocaine and saline treatments failed to show any recovery of evoked responses within 4 hours post-injury, suggesting that lidocaine does not facilitate recovery in this model of spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of lidocaine treatment on acute spinal cord injury. Haghighi, SS., Chehrazi, BB., Higgins, RS., et al.[2019]

In a study involving male Sprague Dawley rats with spinal cord injury, continuous infusion of 5% lidocaine significantly reduced the levels of activated ERK 1/2 and CREB proteins associated with neuropathic pain.

These findings suggest that lidocaine may be an effective treatment for preventing and managing central neuropathic pain after spinal cord injury by targeting specific intracellular signaling pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine attenuates the expression of ERK1/2 and CREB in a neuropathic pain model of rats. Joo, JD., In, JH., Jung, HS., et al.[2019]

In a study involving rats with spinal cord injuries, applying lidocaine rostrally (above the injury site) effectively blocked the negative effects of pain stimulation on locomotor recovery, suggesting a potential therapeutic approach for managing pain after SCI.

Lidocaine not only prevented increased hemorrhage caused by nociceptive stimulation but also improved long-term recovery outcomes, indicating its efficacy in mitigating secondary damage following spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological Transection of Brain-Spinal Cord Communication Blocks Pain-Induced Hemorrhage and Locomotor Deficits after Spinal Cord Injury in Rats. Davis, JA., Bopp, AC., Henwood, MK., et al.[2021]

Lidocaine, a sodium channel blocker, significantly reduced spontaneous neuropathic pain in 24 spinal cord injury patients, regardless of whether they experienced evoked pain, indicating its potential as an effective treatment for this type of pain.

The study found that lidocaine relieved both at-level and below-level neuropathic pain, supporting the idea that sodium channel blockers can help manage pain by acting on neuronal hyperexcitability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous lidocaine relieves spinal cord injury pain: a randomized controlled trial. Finnerup, NB., Biering-Sørensen, F., Johannesen, IL., et al.[2022]

In a study of 21 patients with chronic spinal cord injury pain, lidocaine injections via a lumbar subarachnoid catheter resulted in a significant mean reduction of pain intensity by 37.8% for an average duration of about 123 minutes, compared to placebo.

The response to lidocaine varied among patients, highlighting the complexity of spinal anaesthesia effects on chronic pain, which depend on individual factors such as pain perception and spinal canal anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic spinal anaesthesia in chronic spinal cord injury pain. Loubser, PG., Donovan, WH.[2016]

In a study involving 15 spinal cord injury patients, mexiletine (450 mg/day) was tested for its effectiveness in treating dysesthetic pain, but it showed no significant improvement compared to placebo.

Despite the careful design of the trial, including a randomized, double-blind, crossover approach, mexiletine did not reduce pain levels or improve functional scores in patients with spinal cord injury-related dysesthetic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of mexiletine on spinal cord injury dysesthetic pain. Chiou-Tan, FY., Tuel, SM., Johnson, JC., et al.[2022]

Spinal cord training can enhance future learning and plasticity in the spinal cord after injury, but nociceptive sensitization (pain memory) can impair this learning, indicating a complex relationship between pain and recovery.

In a study involving spinal cord injury models, it was found that nociceptive stimuli, like formalin, can negatively affect spinal learning, suggesting that managing pain is crucial for effective rehabilitation after spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central nociceptive sensitization vs. spinal cord training: opposing forms of plasticity that dictate function after complete spinal cord injury. Ferguson, AR., Huie, JR., Crown, ED., et al.[2021]

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