Motor Tasks + Lidocaine for Dyslexia

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Alberta

Must not be taking: Antiarrhythmics, Anesthetics

Disqualifiers: Severe kidney disease, severe liver disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how speech production affects reading ability in adults with dyslexia. Researchers will test different motor tasks, such as using a lollipop, a bite bar, or numbing with lidocaine (a local anesthetic), to assess their impact on reading performance. Participants will include adults with dyslexia who are fluent in English, have no history of allergic reactions to anesthetics, and can consume sugary products. The study will measure how accurately and quickly participants identify letters and label pictures under these conditions. This research could enhance understanding of speech production's role in reading and improve support for those with dyslexia. As a Phase 4 trial, it involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain heart medications (class I or III antiarrhythmic drugs) or another anesthetic containing lidocaine.

What is the safety track record for lidocaine?

Research has shown that lidocaine is generally safe when used correctly. This well-known local anesthetic numbs specific areas of the body during medical procedures, such as reducing pain during dental work.

The safety of lidocaine depends largely on the dose and its application. Studies indicate that when used in the right amounts, lidocaine is well-tolerated. However, excessive use can cause numbness in the tongue or stomach. Therefore, it is crucial to follow guidelines and have it administered by a healthcare professional.

In this trial, lidocaine numbs the mouth. Past medical use suggests it should be safe when applied as directed. Safety measures will be in place to monitor and quickly address any unexpected reactions for participants in this trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using lidocaine for dyslexia because it offers a novel approach that differs from traditional interventions like educational therapy and cognitive training. Lidocaine, commonly known as a local anesthetic, is being explored for its potential neurological effects on sensory processing and motor tasks, which may be beneficial for individuals with dyslexia. Unlike conventional treatments that primarily focus on reading strategies and phonetic skills, lidocaine's impact on the brain's processing abilities could lead to improved reading and comprehension by directly influencing neural pathways. This innovative method might provide quicker and more direct enhancements in reading abilities for those with dyslexia.

What evidence suggests that this trial's treatments could be effective for dyslexia?

This trial will explore the use of lidocaine, a numbing agent, to help researchers understand how the muscles used for speaking affect reading in adults with dyslexia. Participants may receive lidocaine to numb these muscles, potentially altering how the brain processes reading tasks. Although lidocaine is not a typical treatment for dyslexia, its use in this study helps explore the link between speaking and reading skills. Current evidence has shown that reading programs can improve reading abilities in adults with dyslexia, but the role of speech feedback remains under investigation. This trial aims to determine if feedback from speech muscles is important for reading performance in people with dyslexia. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18, both with and without dyslexia, who are proficient in English and weigh at least 110 lbs. It's not suitable for those with a history of reactions to anesthetics, severe kidney or liver disease, certain heart medications, damaged oral mucosa, allergies to lidocaine ingredients like parabens or artificial colors/flavors, other lidocaine treatments, or if pregnant.

Inclusion Criteria

All participants will be healthy and need to be proficient in English as the assessment materials are only available in English.

I weigh at least 110 lbs (50 kg).

Exclusion Criteria

Participant being pregnant or suspecting that she might be pregnant

I am currently using another medication that contains lidocaine or a similar substance.

I have severe kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Experimental Tasks

Participants complete three experimental tasks under four conditions (no motor task, lollipop, bite bar, and lidocaine) to measure reading performance and response times.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate effects post-experiment and data is collected for analysis.

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine

Trial Overview The study tests how motor tasks (like sucking on a lollipop) and numbing the mouth with Lidocaine affect reading unfamiliar words in adults with dyslexia compared to those without. Participants will perform word recognition and picture labeling tasks under different conditions while their brain activity is monitored.

How Is the Trial Designed?

Group I: Condition Experimental Treatment 1 Intervention

Typical Reader or Individual with Dyslexia

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

Viscous lidocaine can pose a high risk of overdose in pediatric patients due to their altered pharmacokinetics, making doses safe for adults potentially toxic for children.

Benzocaine is recommended as a safer alternative for treating painful mouth lesions in children, as it has a lower incidence of side effects, but if lidocaine must be used, clear and specific dosing instructions should be provided to parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine overdose: another preventable case? Gonzalez del Rey, J., Wason, S., Druckenbrod, RW.[2019]

A case study of a 5-month-old infant revealed that seizures can occur due to toxicity from oral viscous lidocaine, highlighting a serious risk associated with its use in young children.

Despite previous reports of lidocaine toxicity, many healthcare providers remain unaware of its potential adverse effects, emphasizing the need for increased awareness and caution when prescribing topical lidocaine for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity--seizures in an infant caused by (or related to) oral viscous lidocaine use. Smith, M., Wolfram, W., Rose, R.[2019]

Lidocaine has demonstrated protective effects against brain damage in both animal models of ischemia and in vitro studies of low oxygen conditions, suggesting its potential as a neuroprotective agent.

Clinical investigations are exploring lidocaine's ability to prevent postoperative cognitive dysfunction, indicating its possible application in enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective effect of lidocaine: is there clinical potential? Leng, T., Gao, X., Dilger, JP., et al.[2020]

Chronic stress leads to learning and memory dysfunction and damage to pyramidal cells in the CA3 region of the hippocampus, as shown in a study with 32 mice over 21 days.

Lidocaine treatment significantly improved learning and memory performance in stressed mice, reducing the time taken to find a platform in a water maze and increasing the number of healthy pyramidal cells compared to the chronic stress group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of lidocaine on learning and memory dysfunction as well neuropathologic change induced by chronic stress: experiment with mice]. Hu, XY., Wang, DX.[2013]

Lidocaine effectively blocks motor axon conduction at the wrist, with complete recovery of muscle force and nerve conduction within 3 hours after administration, indicating its rapid anesthetic action.

However, even after conduction returns to normal, lidocaine causes prolonged impairment in motor axon excitability, suggesting that its effects may involve reversible structural changes to the nerve membrane, not just the blocking of voltage-gated sodium channels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient impairment of the axolemma following regional anaesthesia by lidocaine in humans. Moldovan, M., Lange, KH., Aachmann-Andersen, NJ., et al.[2021]

Lidocaine, when used for spinal anesthesia, has been associated with a higher risk of neurotoxicity compared to other local anesthetics like bupivacaine and tetracaine, with a risk of persistent lumbosacral neuropathy occurring in about 1 in 1300 procedures for single injections and up to 1 in 200 for continuous spinal anesthesia.

Lidocaine is also linked to transient neurologic symptoms, which can cause significant pain in the buttocks or legs after anesthesia, affecting up to one third of patients, although this pain usually resolves within a week.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential neurotoxicity of spinal anesthesia with lidocaine. Johnson, ME.[2022]

Topical administration of lidocaine can lead to serious toxicity, as demonstrated in a case where a patient experienced neurological issues (convulsions) and cardiological problems (ventricular fibrillation) during a thyroplasty procedure.

Despite the severe reactions, the patient's condition improved satisfactorily, highlighting the importance of monitoring for potential side effects even with local anesthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Toxicity of topical administration of lidocaine]. Gómez Martín-Zarco, JM., Lumbreras Fernández de Córdoba, J., Ortiz García, P.[2019]

N-ethyl lidocaine (QX-314) demonstrated neuroprotective effects in the striatum during ischemic conditions, showing partial recovery of brain function after oxygen and glucose deprivation in laboratory tests.

Unlike lidocaine, which significantly depressed neuronal activity, QX-314 preserved excitatory field potentials and neuronal firing, suggesting it may be a safer option for protecting brain cells during ischemic events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

N-ethyl lidocaine (QX-314) protects striatal neurons against ischemia: an in vitro electrophysiological study. Armogida, M., Giustizieri, M., Zona, C., et al.[2014]

In a study using Sprague Dawley rats, high doses of lidocaine given during specific periods of pregnancy did not show any toxicological or teratogenic effects on the fetuses.

Histological and physical examinations of the fetuses revealed normal development, indicating that lidocaine administration during pregnancy is unlikely to harm fetal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicological assessment of lidocaine in the pregnant rat. Ramazzotto, LJ., Curro, FA., Paterson, JA., et al.[2017]

A study analyzing data from 1995 to 2007 found that articaine 4 percent was significantly associated with neurosensory disturbances (NSDs), especially during mandibular block procedures, indicating a potential safety concern with this anesthetic.

The research suggests that neurotoxicity from the anesthetic itself, rather than the technique of needle penetration, is the primary cause of NSDs, leading to a recommendation for clinicians to consider lower concentration alternatives when performing block anesthesia in the trigeminal area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trigeminal nerve injury associated with injection of local anesthetics: needle lesion or neurotoxicity? Hillerup, S., Jensen, RH., Ersbøll, BK.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05854082?term=AREA%5BBasicSearch%5D(Dyslexia)&rank=8

Impact of Motor Tasks and Lidocaine on Reading ... One direct way to determine the influence of speech production feedback on reading performance is to measure reading performance in adults with dyslexia with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9136755/

Influence of assistive technology applications on dyslexic ... This study explores the influence of assistive technology (AT) on improving the visual perception (VP) and phonological processing (PhP) abilities of students ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2967798/

The Prevention, Diagnosis, and Treatment of Dyslexia - PMC The treatment of dyslexia is based on two main strategies: specific assistance with the impaired learning areas (reading and spelling) and psychotherapy.

4. researchgate.net researchgate.net/publication/364129317_The_effectiveness_of_reading_intervention_in_adults_with_dyslexia_A_systematic_review

The effectiveness of reading intervention in adults with ... Results indicate that providing a literacy training can produce significant gains also in adults with dyslexia and that further research in this ...

5. researchgate.net researchgate.net/publication/338754860_Effectiveness_of_spelling_interventions_for_learners_with_dyslexia_A_meta-analysis_and_systematic_review

A meta-analysis and systematic review - Dyslexia This systematic review and meta-analysis investigated the efficacy of spelling interventions for the remediation of dyslexia and spelling deficits.

6. dentistry.ouhsc.edu dentistry.ouhsc.edu/Portals/1328/assets/Documents/MSDS/xylocaine-MSDS.pdf

MATERIAL SAFETY DATA SHEET Lidocaine: Oral Median Lethal Dose 317mg/kg (rat). May produce numbness of the tongue and anesthetic effects on the stomach.

7. editor.fresenius-kabi.us editor.fresenius-kabi.us/SDSSheets/US-PH-Xylocaine_and_Xylocaine_MPF-March_2024-SDS.pdf

SDS - Fresenius Kabi USA Revised HMIS rating for Personal Protective Equipment (PPE). NOTE: This SDS applies to both 'Xylocaine® (lidocaine HCl Injection, USP)' and ' ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/008816s039lbl.pdf

Xylocaine® 2% Jelly (lidocaine hydrochloride) The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies (see WARNINGS and ...

9. merck.com merck.com/docs/product/safety-data-sheets/ah-sds/Lidocaine%20Hydrochloride%20Formulation_AH_US_EN.pdf

SAFETY DATA SHEET Lidocaine Hydrochloride Formulation Use water spray to cool unopened containers. Remove undamaged containers from fire area if it is safe to do so. Evacuate area. Special protective equipment.

10. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_HOSPLG_LIDOCAINE_HCL_MDV_1PERCENT_50ML.pdf

SAFETY DATA SHEET Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety. In accordance with. 29 CFR 1910.1200, the exact ...