Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05854082
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2023-03-28
Brief Title:
Impact of Motor Tasks and Lidocaine on Reading Unfamiliar Words in Adults With and Without Dyslexia
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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
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 ie reading is built upon acquisition and production of speech Knowledge of how a word sounds and feels when produced ie 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 ie 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 andor program the sequential movements required for speech that is not attributable to deficits in motor physiology eg weakness or spasticity or deficits in language ie 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 ie 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 ie restorative or compensate for deficits ie 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 ie lollipop bite bar lidocaine These somatosensory perturbations have the potential to alter andor decrease the sensory feedback from the articulators in the mouth
It was found that the lollipop had a facilitatory effect ie 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 ie 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 ie 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 participants articulators This clinical trial will be conducted in compliance with this described protocol good clinical practice GCP guidelines and the applicable regulatory requirements
For example children with apraxia of speech a motor speech disorder that results in an impaired ability to plan andor program the sequential movements required for speech that is not attributable to deficits in motor physiology eg weakness or spasticity or deficits in language ie 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 ie 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 ie restorative or compensate for deficits ie 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 ie lollipop bite bar lidocaine These somatosensory perturbations have the potential to alter andor decrease the sensory feedback from the articulators in the mouth
It was found that the lollipop had a facilitatory effect ie 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 ie 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 ie 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 participants articulators This clinical trial will be conducted in compliance with this described protocol good clinical practice GCP guidelines and the applicable regulatory requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None