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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I weigh at least 110 lbs (50 kg).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Accuracy
Functional Near-InfraRed Spectroscopy (fNIRS)
Response Time
Side effects data
From 2014 Phase 4 trial • 40 Patients • NCT0160269240%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine
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
889 Previous Clinical Trials
385,117 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using another medication that contains lidocaine or a similar substance.I have severe kidney disease.I have issues with the lining of my mouth.I have severe liver disease.I am allergic to certain chemicals in Lidocaine Viscous.I weigh at least 110 lbs (50 kg).I am not taking specific heart rhythm medications.
Research Study Groups:
This trial has the following groups:- Group 1: Condition
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this therapy been given the green light by regulatory bodies?
"This treatment has been approved, so it received the highest score of 3 on our safety scale."
Answered by AI
Is enrollment for this research project currently accepting participants?
"Data from clinicaltrials.gov indicate that this particular medical trial is not presently recruiting participants; it first appeared on March 27th 2023 and was last modified 9 May, 2023. However, there are currently twenty other trials actively searching for enrollees."
Answered by AI
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