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
Phase: PHASE4
Conditions: Reading Disorders
Sponsor: University of Alberta

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Protocol 
 
Pro00088290: 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. 
 
NCT Number: NCT05854082 
 
Date document created: October 23, 2019 
 
Date document amended: June 25, 2024 
 
Current version: 4.0 
 
Author: Amberley V. Ostevik 
 
Sponsor: Governors of the University of Alberta 
 

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Details 
 
Pro00088290: How Related Are Speech Production and Reading? An Investigation of the Impact 
of Motor Tasks and Lidocaine on Reading Unfamiliar Words in Adults with Dyslexia. 
 
Primary Investigator: Dr. Jacqueline Cummine 
 
Location: Department of Communication Sciences and Disorders, University of Alberta, 
Edmonton, AB 
 
 
Background 
 
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 (Cummine et al., 
2015) 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 (Hulme & Snowling, 2014). 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 (Catts et al., 1999; 
2000; Vellutino et al., 1991; Wagner et al., 1997; Fletcher et al., 1994; Muter et al., 2004; Hulme 
& Snowling, 2014; Cheema & Cummine, 2017; Cullum, Fleming & Cummine, 2019; 
Pennington & Bishop, 2009, Catts et al., 2002; Tomblin et al., 2000; Hayiou-Thomas, 2010; 
2017; Sices et al., 2007).  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; Duffy, 2013), 
are 1) at a high risk of developing a reading impairment and 2) have increased sensorimotor 
deficits. Newmeyer and colleagues (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 (van der Linde et al., 2013), autism spectrum disorder (ASD; Kientz & Dunn, 1997) 
and attention deficit hyperactivity disorder (ADHD; Dunn & Bennett, 2002). In computational 
modeling, Terband and colleagues (2009; 2010) 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. Nijland et al. (2015) investigated oral form 
discrimination performance in children with CAS (i.e., identification of geometric shapes in the 
mouth) and 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. In our own lab, we have found that oral form discrimination performance in adults is 
related to their reading performance (Cummine et al., in submission, 2020). Finally, Murray et al. 

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(2014) reported that sensory cueing approaches (which place emphasis on the relation between 
movements and auditory and somatosensory information via auditory, and 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.  
 
We have also 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.  
 
We found that the lollipop had a faciliatory 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 faciliatory effect (i.e., faster response times) 
in the phonological lexical decision tasks, but no faciliatory 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, we do not know if these effects (i.e., lollipop, bite bar, lidocaine) 
hold for an adult population with reading disorders.  
 
The investigational product we are requesting approval to use 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, GCP 
and the applicable regulatory requirement(s). 
 
Purpose | Objectives 
 
1. To determine the effects of three different somatosensory perturbations (i.e., lollipop, bite 
bar, lidocaine) on reading performance (i.e., speed, accuracy) in adults with dyslexia.  
2. To compare the findings with a previously completed study using a population of adults 
with typical (i.e., normal) reading abilities (Cummine et al., in press).  
3. To better understand how the speech production system contributes to reading 
performance. The information will help refine the currently accepted speech and reading 
neural models. 
 
Study Design | Trial Design 
 
Participant | Subject Criteria 
 
Inclusion criteria. Thirty adults (i.e., ≥ 18 years of age) of either sex or identified gender with 
diagnosed or self-reported dyslexia will be recruited to participate in a within subjects repeated 
measures design. Thirty participants (18+) without dyslexia will also be recruited as a control 

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group. All participants will need to be proficient in English as the assessment materials are only 
available in English.  
Reading disorders are rarely formally diagnosed because of many factors including but not 
limited to: timing in educational system for assessments, comorbidities with higher priority 
disorders (i.e., apraxia of speech, ADHD, etc.) and cost. Self-reported reading challenges are 
more accurate at identifying potential participants. Self-reported reading disorders will be 
confirmed/verified prior to enrollment via standardized reading measures.  
 
Exclusion criteria. Participants must have no personal or family history of adverse reactions to 
anesthetics to complete all the conditions. Participant who cannot consume sugary products will 
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; negative pregnancy test is required for women of 
childbearing potential. 
 
Women of childbearing potential (WOCBP), i.e. assigned at birth females who experienced 
menarche and are not sterile or postmenopausal, may be included in the study, provided that they 
use an acceptable method of contraception, such as: hormonal contraceptives (e.g. combined oral 
contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or 
intrauterine system (IUS); (partner’s) vasectomy, tubal ligation; double barrier methods of 
contraception (e.g. male condom plus spermicide , cervical cap plus spermicide, diaphragm plus 
spermicide). Abstinence is acceptable provided that it is consistent with the participant’s usual 
lifestyle. 
 
Adult participants must weigh at least 50 kg or 110 lbs to avoid any possible toxic effects from 
the lidocaine. 
 
Qualified Investigator (QI) Physician:  
Dr. Caroline Jeffrey, MD 
Suite 903 
College Plaza 
8215 112 Street NW 
Edmonton, AB 
Phone: 780.540.2111 
Fax: 780.540.2114 
 
Subjects that do not meet these criteria when contacting researchers will not be scheduled for 
collection. Participants will be immediately withdrawn (i.e., collection stopped) if they are 
unable to perform reading assessments, they report any adverse reaction or a desire to 
discontinue. If the participant withdraws or their participation discontinued, their data will be 
retained for analysis, unless the participant requests the data be destroyed. Any withdrawn 
participants will be replaced with additional recruitment. No follow-up is planned for withdrawn 

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participants unless they experience an adverse reaction that require medical follow-up and 
reporting. 
 
 
Figure 1. Schematic of repeated measures design 
 
Methodology 
 
The primary endpoint is reading response time and accuracy for each word type with and without 
oral perturbation.  
 
The individual will be required to attend one collection session at the Clinical Sciences Building 
at the University of Alberta which will last no more than 90-minutes. Twenty percent (i.e., 12) of 
recruited participants will complete the the protocol below over two separate 60-minute sessions 
to investigate the effects of order, fatigue, etc. 
 
During the session, participants will:  
1. Read and complete an information and consent form (less than 10 minutes to complete). 
2. Complete a pre-collection questionnaire to gather information such as age, sex and 
allergies (less than 5 minutes to complete). 
3. Any participant reporting a personal or family history of adverse reactions to anesthetics 
will not be enrolled. If a participant reports any concerns or adverse reactions during the 
collection session, collection will immediately stop, and their participation discontinued. 
4. If the participant is enrolled, they will be assigned a randomly generated identification 
number. All of their files and documents will be labelled with this number.  
5. Each participant will also be randomly assigned to one of six possible task orders. 
Neither participants nor experimenters will be blinded to these conditions. This is 
documented in a hard-copy log. 
6. Participants will be fit with an fNIRS cap to measure brain signals. 
7. Then complete three computer generated tasks under four conditions (a, b and c will be 
randomized): 
a. No sensory perturbation 
b. Lollipop 
c. Bite bar 
d. Lidocaine – this condition will always be completed last. 

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8. The comparators to the lidocaine are no sensory perturbation, a candy lollipop and candy 
bite bar. All candy is obtained from the grocery store and are individually packaged. The 
lidocaine will be dispensed by a pharmacist and administered by the research team. 
9. For the three computer generated tasks (randomly administered), accuracy and response 
time will be measured by the computer: 
a. Task 1 (orthographic lexical decision): involves deciding whether a series of 
letters formulates a word or a nonword. Individuals will press the 'g' key if it is a 
word and the 'h' key if it is a nonword. Stimuli are single, monosyllabic, 4-7 letter 
length, words and nonwords. 
b. Task 2 (phonological lexical decision): involves deciding whether a series of 
letters sounds out a word or a nonword. Individuals will press the 'g' key if it is a 
word and the 'h' key if it is a nonword. Stimuli are single, monosyllabic, 4-7 letter 
length, words and nonwords. 
c. Task 3 (picture categorization): requires participants to make a judgement about 
whether a visually presented object is an animal or not. They will press 'g' if the 
object is an animal, and 'h' if it is not an animal. 
10. Complete a short questionnaire rating and describing the numbness caused by the 
lidocaine (less than 5 minutes to complete).  
 
Treatment 
 
Each participant will swish 15 mL (one tablespoon) of the Viscous Lidodan 2% in their mouth 
for 60 seconds, then spit into a sink. This amount is the recommended manufacturer dosage. This 
will occur once during the one collection session. Viscous Lidodan 2% (i.e., Lidocaine 
Hydrochloride Oral Topical Solution 2% USP) is a topical anesthetic. The numbing effects of 
Viscous Lidodan 2% should take effect after five minutes and last around 30 minutes. 
 
No other topical oral anesthetics are permitted to have been administered in the day before the 
trial. No details are required on any other medications.  
 
Safety Assessment 
 
Safety Assessment/Monitoring and Risk Mitigation. Each participant completes a pre-collection 
questionnaire where it asks all subjects to report any personal or family history of adverse 
reactions to anesthetics. This is a hard-copy questionnaire that is completed by the participant 
after the informed consent form, but before collection begins. It is reviewed together with the 
experimenter and participant before collection commences. Participants will be informed prior to 
beginning the experiment that they may withdraw at any time. They will be monitored 
throughout the experiment by research staff for signs of distress or adverse reactions (e.g., 
redness, itching or swelling of skin, hives, burning, stinging, or any other skin problems, 
swelling of the neck area, or any difficulty with breathing). The QI will be available via 
phone/pager during administration of Lidocaine in case of adverse event(s) for 
assessment/triage/treatment/follow-up as clinically indicated. 
 
If any reactions or adverse effects (i.e., redness, itching or swelling of skin, hives, burning, 
stinging, or any other skin problems, swelling of the neck area, or any difficulty with breathing) 

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are observed by the experimenters during collection, the QI will be called and the experimenter 
will escort the participant to the hospital emergency room connected to the Clinical Sciences 
Building. After the collection session is over, the participant will be instructed to report to their 
nearest emergency room if they experience any reactions or adverse effects. Participants will be 
informed that they should avoid eating and drinking and exposure to extreme hot or cold 
temperatures (e.g. food, drink) until complete sensation has returned. The numbness may also 
increase the risk of unintentional biting (e.g., cheek). 
 
The lidocaine condition will always be lastly completed so its effects will not interfere with the 
other conditions. Each participant will be asked to complete a questionnaire after collection to 
localize and rank their numbness on a provided schematic. And adverse events reported by the 
participant will be recorded on this document and reported immediately to the qualified 
investigator. After the collection session is over, the participant will be instructed to report to 
their nearest emergency room if they experience any reactions or adverse effects. Topical 
anesthetics in the mouth may impair swallowing. The numbness may also increase the risk of 
unintentional biting (e.g., cheek). The qualified investigator, an otolaryngology head and neck 
surgeon, will follow-up with the subject as she deems appropriate. All serious unexpected 
adverse drug reactions (SUSARs) will be reported to Health Canada as mandated per C.05.014 
(1) of the FDR. 
 
Budget Considerations 
 
Participants will be offered a small honorarium ($20.00) for taking part in the study. 
 
Experiment Location 
 
6-104, Clinical Sciences Building, University of Alberta. 
 
Statistical Analysis 
 
Given the between groups nature of the sensorimotor perturbation (i.e., lidocaine vs. no 
lidocaine groups), we will first run a 2 x 2 x 4 x 2 ANOVA with group (lidocaine vs. no 
lidocaine), task (spell vs. sound), word type (exception words, regular words, 
pseudohomophones, nonwords), and time (pre-lidocaine vs. post-lidocaine), as 
the factors of interest. If the 4-way interaction is significant, a series of mixed ANOVAs will be 
run to test the effect of sensorimotor perturbation for each of the reading tasks. The 
independent variables will be time (pre-perturbation vs. post-perturbation), word type 
(exception, regular, pseudohomophone, nonword) and group. An ANOVA was also be run to test 
the effect of the sensorimotor perturbation for the control picture categorization task, with the 
independent variables including time (pre-perturbation vs. post-perturbation) and group. The 
dependent variable will include response time and accuracy. Bonferroni corrected t -tests were 
used to explore significant effects of the lidocaine on task performance. No interim analyses are 
planned. The data will be analyzed when thirty subjects have participated. 
 
Data | Documents 
 

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The data will be kept confidential and no personally identifying information will be linked to the 
data. All data will be reported in aggregated form. The data and consent forms will be stored 
securely at the University of Alberta by the principal investigator. The investigators and 
institution will permit trial-related monitoring, audits, IRB/IEC review, and regulatory 
inspections, providing direct access to source data and documents. 
 
All data and documents relating to the clinical trial will be stored for a minimum of twenty-five 
years after completion of the study.