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CompletedNCT05854082Updated Feb 5, 2026

Impact of Motor Tasks and Lidocaine on Reading Unfamiliar Words in Adults With and Without Dyslexia

A Phase 4 interventional study of Lidocaine 2% Polyampoule in Reading Disorders, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by University of Alberta · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Recent claims report that reading ability is partially dependent on speech production. While the evidence for this claim is compelling, it is not known to what extent, the speech production system contributes to successful reading performance in adult populations with dyslexia. One direct way to determine the influence of speech production feedback on reading performance is to measure reading performance in adults with dyslexia with an added motor component (i.e., sucking on a lollipop, holding a bite bar or numbing their oral mucosa with lidocaine).

To adults with and without dyslexia 18 years of age and older (60 in total; 30 in each group), three experimental tasks will be administered under four conditions (no motor task, lollipop, bite bar and lidocaine). The first task asks whether the letter string being presented is a word or a nonword. Secondly, a motor sequencing task will be administered where adults will be asked to label pictures. For all tasks, the accuracy and speed of responses will be measured by a computer while participants wear a fNIRS cap.

Read the detailed description

While there are no clinical trials that have explored the explicit connection between reading and speech production (as the current study is proposing) the print-to-speech model provides a framework for understanding how the recognition of visual word forms (i.e., reading) is built upon acquisition and production of speech. Knowledge of how a word sounds and feels when produced (i.e., auditory and somatosensory feedback, respectively) scaffolds the development of knowledge about what a word looks like. This notion that reading development is heavily dependent on oral language skills follows from many studies providing evidence that oral language skills (i.e., vocabulary, syntax) and phonological awareness skills are predictors of both typical and deficient reading ability. Further, there are several nonclinical studies that provide convincing evidence that this connection needs to be better understood.

For example, children with apraxia of speech, a motor speech disorder that results in an impaired ability to plan and/or program the sequential movements required for speech that is not attributable to deficits in motor physiology (e.g., weakness, or spasticity) or deficits in language (i.e., reduced comprehension), are 1) at a high risk of developing a reading impairment and 2) have increased sensorimotor deficits. An investigation from 2009 evaluated the performance of 38 children with suspected apraxia of speech (CAS) on the Sensory Profile, a standardized assessment of sensory processing in children. Children with CAS had atypical sensory processing in five sensory factors, including oral sensory sensitivity. Increased oral sensory sensitivity in comparison to typically developing children has also been reported in children with specific language impairment, autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD). In computational modelling, it has also been reported that the core impairment in CAS may be impaired feedforward commands secondary to reduced or degraded oral sensitivity, which fits well within the print-to-speech framework. An investigation of oral form discrimination performance in children with CAS (i.e., identification of geometric shapes in the mouth) reported that children with CAS scored significantly lower than typically developing children. Lower discrimination abilities are proposed to be an indicator of poor somatosensory function.

It has also been reported that sensory cueing approaches (which place emphasis on the relation between movements and auditory and somatosensory information via auditory, touch, pressure, kinesthetic and proprioceptive cues) are the most effective for treatment of CAS. Such results suggest that sensory cueing approaches either target the underlying impairment directly (i.e., restorative) or compensate for deficits (i.e., compensatory). The identification of sensory difficulties in children with CAS is important to understand speech characteristics and treatment efficacy in this population. These findings warrant additional investigations to understand if and to what extent somatosensory processing contributes to speech production and reading deficiencies in healthy and impaired adult and pediatric populations.

The investigators have found that oral form discrimination performance in adults is related to their reading performance and previously attempted to determine the influence of speech production feedback on reading performance by measuring reading performance in adults while adding an additional motor component (i.e., lollipop, bite bar, lidocaine). These somatosensory perturbations have the potential to alter and/or decrease the sensory feedback from the articulators in the mouth.

It was found that the lollipop had a facilitatory effect (i.e., faster response times) in the orthographic lexical decision tasks but no effect on the phonological lexical decision tasks or picture categorization tasks. In contrast, the lidocaine had a facilitatory effect (i.e., faster response times) in the phonological lexical decision tasks, but no facilitatory effects on the orthographic lexical decision tasks or picture categorization. Finally, the bite bar did not impact performance in any of the three tasks. However, it is not known if these effects (i.e., lollipop, bite bar, lidocaine) hold for an adult population with reading disorders. While completing these tasks under these conditions, brain activity will be measured using an functional near-infrared spectroscopy (fNIRS) system.

The approved investigational product is Lidocaine Hydrochloride Oral Topical Solution 2% USP. This oral topical anesthetic will temporarily numb the participant's articulators. This clinical trial will be conducted in compliance with this described protocol, good clinical practice (GCP) guidelines and the applicable regulatory requirement(s).

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Conditions studied

  • Reading Disorders

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03

In context

Dyslexia

127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.

This study's enrollment of 56 is below the median of 71 across 106 interventional studies indexed under Dyslexia.

Browse Dyslexia studies →

Lead sponsor

University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All participants will be healthy and need to be proficient in English as the assessment materials are only available in English.
  • Adult participants must weigh at least 50 kg or 110 lbs to avoid any possible toxic effects from the lidocaine.

Exclusion criteria

Exclusion Criteria:

  • Participants must have no personal or family history of adverse reactions to anesthetics to complete all the conditions.
  • Participants who cannot consume sugary products will also be excluded.
  • Additional exclusion criteria include: severe kidney disease; severe liver disease; treatment with class I antiarrhythmic drugs (such as mexiletine) or class III antiarrhythmic drugs (such as amiodarone)
  • lack of integrity of oral mucosa]
  • allergy to non-medicinal ingredients and preservatives (and related compounds) of Lidocaine Viscous, such as methylparaben, propylparaben, paraaminobenzoic acid, saccharin, artificial colours and flavour
  • concomitant use of another anaesthetic containing lidocaine or another amide
  • participant being pregnant or suspecting that she might be pregnant
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Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Other
    Condition

    Typical Reader or Individual with Dyslexia

    Drug: Lidocaine 2% Polyampoule

Interventions

  • Three intervention conditions in a repeated measures design - lidocaine; no perturbation, candy (lollipop)

    Also known as: No perturbation, Candy perturbation

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What researchers measure

Primary outcomes

  1. Functional Near-InfraRed Spectroscopy (fNIRS)

    Cortical activation in different brain regions using blood oxygenation changes measured using infrared light

    Time frame: 1 day

  2. Accuracy

    Response to visually presented reading stimuli (i.e., correct or incorrect) recorded by the participant pressing on keyboard buttons

    Time frame: 1 day

  3. Response Time

    Response time (in milliseconds) to visually presented reading stimuli recorded by the participant pressing on keyboard buttons

    Time frame: 1 day

07

Study locations

1 site
  • Department of Communication Sciences and Disorders, University of Alberta
    Edmonton, Alberta T6G 2R3, Canada
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References and documents

Publications

  • Cummine J, Patel DH, Holmes M, Ostevik A, Aalto D. Towards an understanding of somatosensory perturbation on covert speech production: a functional near infrared spectroscopy study. Front Hum Neurosci. 2026 May 7;20:1757752. doi: 10.3389/fnhum.2026.1757752. eCollection 2026. PubMed 42179727 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2023 to primary completion in Jul 2025, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2023
First posted
May 11, 2023
StartActual
Aug 24, 2023
Primary completionActual
Jul 10, 2025
CompletionActual
Jan 13, 2026
Last update
Feb 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05854082
Responsible party
Sponsor
First posted
May 11, 2023
Start date
Aug 24, 2023
Primary completion
Jul 10, 2025
Completion
Jan 13, 2026
Last update
Feb 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Lidocaine

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