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

Trial Summary

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 data supports the effectiveness of the treatment Mismatch negativity for speech perception in autism and Fragile X Syndrome?

The research suggests that mismatch negativity (MMN) can reflect how the brain processes sound changes, which is important for understanding speech. In autistic children, larger and faster MMN responses were linked to more autistic traits and sensory features, indicating that MMN might help in understanding auditory processing in autism. ^{1 2 3 4 5}

Is the mismatch negativity (MMN) treatment safe for humans?

The research on mismatch negativity (MMN) primarily focuses on its use as a tool to study auditory processing in conditions like autism, rather than as a treatment. There is no specific safety data provided for MMN as a treatment, but it is generally used in non-invasive studies, suggesting it is safe for human participants. ^{3 4 5 6 7}

How does this treatment for speech perception in autism and Fragile X Syndrome differ from other treatments?

This treatment is unique because it focuses on understanding and improving auditory processing and speech perception through the use of mismatch negativity (MMN), a brain response that helps evaluate how the brain detects changes in sounds. Unlike other treatments that might focus on behavioral or pharmaceutical approaches, this method uses neurophysiological measures to target the specific auditory processing challenges faced by individuals with autism and Fragile X Syndrome. ^{1 3 4 6 8}

What is the purpose of this trial?

The goal of this study is to identify which brain regions are active during speech-in-noise perception, as well as how those regions interact. The investigators are studying brain activation during speech-in-noise in autism and controls as well as individuals with Fragile X Syndrome. The main question\[s\] it aims to answer are: 1) How does the brain's response to background noise affect a person's ability to understand speech? 2) Can visual cues improve hearing in background noise? Participants will complete the following: * hearing tests * cognitive and behavioral measures * questionnaires about their symptoms * both passive and active hearing tasks while brain activity is recorded with a neuroimaging cap Results will be compared between individuals with autism with and without Fragile X Syndrome as well as individuals without autism.

Research Team

Elizabeth Smith, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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 an audiogram that is within the normal range (PTA ≤ 20 dB HL).

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Psychophysiological Correlates of Developmental Changes in Healthy and Autistic Boys. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Abnormalities in cortical auditory responses in children with central auditory processing disorder. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Neurophysiologic bases of speech discrimination. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A Preliminary Study Characterizing Subcortical and Cortical Auditory Processing and Their Relation to Autistic Traits and Sensory Features. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis and systematic review of the literature characterizing auditory mismatch negativity in individuals with autism. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Mismatch negativity in children with autism and typical development. [2018]

7. Brazil pubmed.ncbi.nlm.nih.gov

Mismatch Negativity in Children and Adolescents with Autism Spectrum Disorder. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Delayed mismatch field for speech and non-speech sounds in children with autism. [2022]