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.
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
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).
- Conditions
- Reading Disorders
- 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 group | Role | What they receive |
|---|---|---|
| Condition | Other | Typical 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.
Functional Near-InfraRed Spectroscopy (fNIRS)
Cortical activation in different brain regions using blood oxygenation changes measured using infrared light
Measured: 1 day
Accuracy
Response to visually presented reading stimuli (i.e., correct or incorrect) recorded by the participant pressing on keyboard buttons
Measured: 1 day
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.
- First posted11 May 2023
- Study start24 Aug 2023
- Primary completion10 Jul 2025
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reading DisordersStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05854082
- Acronym / sponsor ID
- Pro00088290
- Conditions
- Reading Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Condition | Other | Drug: Lidocaine 2% PolyampouleTypical Reader or Individual with Dyslexia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 2% PolyampouleAlso: No perturbation, Candy perturbationThree intervention conditions in a repeated measures design - lidocaine; no perturbation, candy (lollipop) | Drug | Condition |
Primary outcome
Functional Near-InfraRed Spectroscopy (fNIRS)
Time frame: 1 day
Cortical activation in different brain regions using blood oxygenation changes measured using infrared light
Accuracy
Time frame: 1 day
Response to visually presented reading stimuli (i.e., correct or incorrect) recorded by the participant pressing on keyboard buttons
Response Time
Time frame: 1 day
Response time (in milliseconds) to visually presented reading stimuli recorded by the participant pressing on keyboard buttons
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 42179727Cummine 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.
- Individual participant dataSharing planned: No
Related trials for Reading Disorders
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
Recruiting
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Developmental Dyslexia, Reading Problem
Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Active, not recruiting
Promoting Caregiver Implementation of an Effective Early Learning Intervention
Developmental Language Disorder, Reading; Difficult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.