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Motor Tasks + Lidocaine for Dyslexia

Phase 4
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult participants must weigh at least 50 kg or 110 lbs to avoid any possible toxic effects from the lidocaine.
Be older than 18 years old
Must not have
Concomitant use of another anaesthetic containing lidocaine or another amide
Severe kidney disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test whether adding a motor task (like sucking a lollipop) while reading can improve reading accuracy/speed in adults with dyslexia.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from Lidocaine may include numbness of the mouth area, possible mild allergic reactions if sensitive to its components but no significant systemic side effects are expected due to local application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 110 lbs (50 kg).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently using another medication that contains lidocaine or a similar substance.
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I have severe kidney disease.
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I have issues with the lining of my mouth.
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I have severe liver disease.
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I am allergic to certain chemicals in Lidocaine Viscous.
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I am not taking specific heart rhythm medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Accuracy
Functional Near-InfraRed Spectroscopy (fNIRS)
Response Time

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ConditionExperimental Treatment1 Intervention
Typical Reader or Individual with Dyslexia

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
940 Previous Clinical Trials
433,971 Total Patients Enrolled

Media Library

Condition Clinical Trial Eligibility Overview. Trial Name: NCT05854082 — Phase 4
Reading Disorder Research Study Groups: Condition
Reading Disorder Clinical Trial 2023: Condition Highlights & Side Effects. Trial Name: NCT05854082 — Phase 4
Condition 2023 Treatment Timeline for Medical Study. Trial Name: NCT05854082 — Phase 4
~10 spots leftby Apr 2025
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