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Reading DisordersPhase 4NCT05854082

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

A Phase 4 study testing Lidocaine 2% Polyampoule in people with Reading Disorders, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Reading Disorders
What is being tested?
Lidocaine 2% Polyampoule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteCanada
Study dates
24 Aug 2023to 13 Jan 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Department of Communication Sciences and Disorders, University of Alberta

    Edmonton, Alberta, T6G 2R3

Other trials in Canada

About this study

Official title: How Related Are Speech Production and Reading? An Investigation of the Impact of Motor Tasks and Lidocaine on Reading Unfamiliar Words in Adults With and Without Dyslexia

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).

Being tested
Lidocaine 2% Polyampoule
Medical subject headings
Dyslexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine 2% PolyampouleDrug

    Also called No perturbation, Candy perturbation

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

Study groups in NCT05854082
Study groupRoleWhat they receive
ConditionOtherTypical Reader or Individual with Dyslexia
Receives: Drug: Lidocaine 2% Polyampoule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Near-InfraRed Spectroscopy (fNIRS)

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

    Measured: 1 day

  2. Accuracy

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

    Measured: 1 day

  3. Response Time

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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start24 Aug 2023
  3. Primary completion10 Jul 2025
  4. Study completion13 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05854082
Sponsor's protocol ID
Pro00088290
Status last verified
Feb 2026
First submitted
28 Mar 2023
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine 2% Polyampoule in people with Reading Disorders, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Near-InfraRed Spectroscopy (fNIRS) (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05854082, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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