Speech Perception for Autism and Fragile X Syndrome

Overseen By Elizabeth Smith, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: EEG-affecting medications

Disqualifiers: Hearing loss, Uncorrected vision, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the brain processes speech in noisy environments for individuals with autism and Fragile X Syndrome. Researchers aim to identify which brain areas activate during these tasks and whether visual cues can enhance understanding. Participants will undergo hearing tests and complete tasks while wearing a neuroimaging cap to track brain activity, using a method called mismatch negativity, which measures brain response to auditory stimuli. The study seeks individuals with normal hearing and vision, who speak English as their first language, and meet specific criteria for autism, Fragile X Syndrome, or have no neurological issues. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on sensory processing in autism and Fragile X Syndrome.

Will I have to stop taking my current medications?

The trial requires that participants do not take medications known to affect EEG signal (a test that measures brain activity). If your current medications affect EEG, you may need to stop taking them.

What prior data suggests that this protocol is safe for participants?

Research has shown that mismatch negativity (MMN) is a safe and well-tolerated method for studying brain activity. MMN is a brain response triggered by changes in sound and requires no active participation. Studies have found that researchers commonly use MMN in autism and Fragile X Syndrome research.

No reports indicate any negative effects from MMN. It simply observes how the brain reacts to different sounds. As a non-invasive method, it doesn't involve surgery or entering the body. Participants wear a special cap that measures brain activity while they listen to sounds, making it a low-risk way to learn about brain function in various conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of mismatch negativity in speech perception for autism and Fragile X Syndrome because it offers a fresh approach to understanding these conditions. Unlike traditional behavioral therapies or medications that focus on symptoms, mismatch negativity leverages neuroimaging to measure brain responses to repeated speech sounds. This method targets the brain's natural ability to process auditory information, potentially providing insights into the neural pathways involved in speech perception. By focusing on the brain's electrical activity, this approach could pave the way for more personalized and effective interventions.

What evidence suggests that this trial's treatments could be effective for speech perception in autism and Fragile X Syndrome?

Research has shown that the mismatch negativity (MMN) response plays a crucial role in how individuals with autism and Fragile X Syndrome process speech sounds. Studies have found that those with autism often exhibit differences in their MMN responses, such as longer delays and stronger reactions compared to others. This suggests that their brains process sounds differently. In individuals with autism, the MMN response is less lateralized, which might affect speech comprehension, especially in noisy environments. During this trial, participants will hear repeated speech sounds while wearing a neuroimaging cap to study the MMN response. Researchers are investigating the MMN response as a potential indicator of language difficulties related to autism, which could aid in understanding and improving speech perception in these individuals. ^{4 6 7 8 9}

Who Is on the Research Team?

Elizabeth Smith, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for individuals with Autism Spectrum Disorder or Fragile X Syndrome who have normal hearing and vision, no neurological or psychiatric diagnoses besides autism, were not born prematurely, are not on medications affecting EEG signals, and speak English as their first language. Relatives with these conditions disqualify participation.

Inclusion Criteria

None of my siblings or parents have Autism or Fragile X Syndrome.

I do not have any neurological or psychiatric conditions.

You have not given birth before 36 weeks gestation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete phone-based consent, interviews, and baseline assessments including cognitive and behavioral measures, questionnaires, and hearing tests.

1-2 weeks

1 visit (phone-based), 1 visit (in-person)

Neuroimaging and Behavioral Tasks

Participants complete neuroimaging tasks with fNIRS and EEG while performing speech-in-noise perception tasks.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects and data is analyzed for study outcomes.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mismatch negativity

Trial Overview

The study investigates brain activity during speech-in-noise perception in people with autism—with and without Fragile X Syndrome—and those without autism. It involves hearing tests, cognitive assessments, questionnaires about symptoms, and neuroimaging to record brain responses to sound.

How Is the Trial Designed?

Group I: Speech Sounds Experimental Treatment 1 Intervention

Participants will hear repeated speech sounds while wearing a neuroimaging cap.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

In a study of 23 children aged 9-12, those with central auditory processing disorder (CAPD) showed significant delays and reduced amplitudes in the N2 auditory response compared to children without CAPD, indicating potential neural deficits.

The findings suggest that the N2 response could serve as a marker for identifying auditory processing issues in children with CAPD, highlighting differences in how their brains process auditory information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abnormalities in cortical auditory responses in children with central auditory processing disorder. Koravand, A., Jutras, B., Lassonde, M.[2018]

The study found that boys with mild to moderate autism showed less lateralization in mismatch negativity (MMN) responses to sound duration changes, indicating differences in sound processing compared to healthy boys.

Larger MMN amplitudes in response to speech-like sounds were linked to better verbal fluency and executive function in autistic boys, suggesting that these neural responses may reflect neurodevelopmental progress rather than serve as clear indicators to differentiate between autistic and non-autistic individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychophysiological Correlates of Developmental Changes in Healthy and Autistic Boys. Weismüller, B., Thienel, R., Youlden, AM., et al.[2019]

Children with autism spectrum disorder (ASD) showed a significant delay in the magnetic mismatch field response to sounds compared to typically developing children, indicating potential difficulties in sound discrimination.

This delay in processing transient sound differences may contribute to language impairments in children with ASD, suggesting that their challenges with language could be linked to how they perceive and interpret sounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed mismatch field for speech and non-speech sounds in children with autism. Oram Cardy, JE., Flagg, EJ., Roberts, W., et al.[2022]

The mismatch negativity (MMN) is a valuable tool for objectively assessing how the brain detects changes in sound, which is crucial for understanding speech perception across different populations, including normal-hearing individuals and those with auditory impairments.

Research using MMN has revealed insights into how the brain processes subtle acoustic differences and adapts to changes in auditory input, highlighting its potential for studying central auditory mechanisms and plasticity in both humans and animal models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurophysiologic bases of speech discrimination. Kraus, N., McGee, T., Carrell, TD., et al.[2019]

The meta-analysis of 67 experiments revealed that young children with autism spectrum disorder (ASD) show reduced mismatch negativity (MMN) amplitude compared to typically developing controls, particularly when using nonspeech sounds.

Despite the findings, the overall analysis did not show significant group differences due to small sample sizes and a lack of diverse participant demographics, highlighting the need for more rigorously designed studies focusing on underrepresented ASD populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis and systematic review of the literature characterizing auditory mismatch negativity in individuals with autism. Schwartz, S., Shinn-Cunningham, B., Tager-Flusberg, H.[2021]

In a study involving 10 autistic children and 21 typically developing peers, no differences were found in the subcortical auditory brainstem response (speech-ABR), indicating similar basic auditory processing between the groups.

However, autistic children exhibited larger P1 amplitudes and faster Mismatch Negativity (MMN) responses, suggesting enhanced cortical auditory processing, which correlated with greater autistic traits and sensory features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Study Characterizing Subcortical and Cortical Auditory Processing and Their Relation to Autistic Traits and Sensory Features. Matsuba, ESM., Prieve, BA., Cary, E., et al.[2022]

Children with autism show significantly smaller mismatch negativity (MMN) amplitudes in response to unattended auditory stimuli compared to typically developing children, indicating abnormal automatic auditory processing.

When children with autism actively attend to auditory stimuli, their MMN amplitudes are typical, suggesting that attention plays a crucial role in their auditory discrimination abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mismatch negativity in children with autism and typical development. Dunn, MA., Gomes, H., Gravel, J.[2018]

Children and adolescents with autism spectrum disorder (ASD) showed significantly higher latency and amplitude values in the mismatch negativity (MMN) component compared to a control group, indicating differences in auditory processing.

The study involved 68 participants, with the ASD group demonstrating altered auditory perception, which may reflect underlying neural mechanisms related to auditory change detection in individuals with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mismatch Negativity in Children and Adolescents with Autism Spectrum Disorder. Mayerle, MCCDS., Riesgo, R., Gregory, L., et al.[2023]

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sciencedirect.com

sciencedirect.com/science/article/pii/S0021992420300654

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pmc.ncbi.nlm.nih.gov/articles/PMC4493458/

Autism Spectrum Disorder (ASD) and Fragile X Syndrome (FXS)

Mismatch Negativity (MMN) = An ERP component that occurs due to an odd stimulus in a sequence of stimuli. It can be elicited regardless of the individual's ...

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pmc.ncbi.nlm.nih.gov

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