Neural Mechanisms of Sensory Processing Anomalies

Understanding the Neural Mechanism Behind Sensory Processing Anomalies

To assess sensory processing anomalies in neurotypical children, children with autism spectrum disorder, and attention-deficit hyperactivity disorder, particularly within the vibrotactile and auditory sensory modalities.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Sensory Processing Disorder
• Intervention / Treatment: Behavioral: Discrimination Acuity test; Diagnostic test: Transiently Evoked Otoacoustic Emission; Other: Questionnaires; Behavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V); Diagnostic test: Clinical tests of ASD; Other: Electroencephalography (EEG) with auditory or vibrotactile stimuli; Diagnostic test: Clinical tests of ADHD

Detailed Description

Neurodevelopmental disorders, such as attention-deficit-hyperactivity disorder (ADHD) and autism spectrum disorder (ASD), have been associated with a high prevalence of sensory processing anomalies. With the update of the diagnostic manuals International Classification of Diseases eleventh revision (ICD-11) and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), more emphasis has been given to the sensory symptoms of both these disorders. The demand of reliable and valid quantitative measurements of sensory processing anomalies are therefore increasing as such metrics has the potential to assist clinical decision-making e.g., in (differential) diagnostics and treatment response evaluation and prediction. The present observational study focuses on auditory and tactile processing. Hearing and touch are two of the most frequency reported modalities in which individuals with ASD experience sensory anomalies. In addition, adequate auditory and tactile processing are presumed fundamental in the emergence of various social and cognitive functions such as the development of language. Elucidating the sensory symptoms by means of psychophysics, neuroimaging, and quantitative measures of peripheral sensory organs could elucidate the underlying (neuro)physiology of sensory anomalies in ASD and ADHD.

The present project aims to elucidate the physiological substrates of abnormal sensory processing by conducting a battery of tests in children with ASD, ADHD, and neurotypical children. First, a series of questionnaires will be administered to acquire a (clinical) description of the participants (Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V); Autism Quotient (AQ, child version); Childhood Behavioral Checklist (CBCL 6-16); ADHD-Ration Scale (ADHD-RS); Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2); Use of pharmacotherapy). A standardized caregiver-reported sensory profile questionnaire will serve as the primary outcome (Sensory Profile 2, Child version). Second, transiently evoked otoacoustic emissions will be measured in order to account for peripheral mechanisms of hearing as well as their contralateral suppression to measure efferent auditory system functioning. Third, a psychophysic task will be conducted for the purpose of estimating the just-noticeable difference to auditory loudness and vibrotactile displacement intensities followed by a subjective categorical loudness scale experiment. Finally, two electroencephalographic experiments will be performed: a frequency tagging paradigm with interspersed pitch oddballs and a classical sensory gating paradigm using vibrotactile stimuli and auditory clicks.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Sabata Gervasio; Phone Number: 9940 8820; Email: saba@hst.aau.dk
• Study Contact Backup: Name: Daniel Skak Mazhari-Jensen

Study Locations

• Denmark
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, 9260
      • Recruiting
      • Health Science and Technology
      • Contact: Sabata Gervasio; Phone Number: 9940 8820; Email: saba@hst.aau.dk
      • Contact: Daniel Skak Mazhari-Jensen; Email: daskmaje@hst.aau.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population include three well-defined groups of subjects:

1. Children with a diagnosis of ASD from the local Child and Adolescent Psychiatry clinic.
2. Children with a diagnosis of ADHD from the local Child and Adolescent Psychiatry clinic.
3. Neurotypical children without any psychiatric or neurologic diagnosis.

Description

Inclusion Criteria:

• Clinically diagnosed with either ADHD, ASD, or no diagnosis (typical development)
• Between 8-15 years old

Exclusion Criteria:

• Familiar history of schizophrenia and depression.
• Epilepsy, cerebral palsy, traumatic brain injury
• Musculoskeletal illnesses
• Hearing or visual impairment that cannot be corrected
• Lack of ability to cooperate
• Parents cannot read Danish

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with Autism Spectrum Disorder; Children with a confirmed diagnosis of autism spectrum disorder made by a qualified psychiatrist.	Behavioral: Discrimination Acuity test; Estimating the just-noticeable difference of auditory loudness and vibrotactile displacement to fit a psychometric function for each modality with parameters: threshold, slope, sensitivity, and response criterion.; Diagnostic test: Transiently Evoked Otoacoustic Emission; Examination of integrity of outer hair cells in the inner ear; with and without contralateral suppression.; Other: Questionnaires; Caregiver questionnaires send to parents online to acquire demographic information Autism Quotient (AQ), Child Behavior Checklist (CBCL6-16), Sensory Profile 2 (SP-2).; Behavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V); Estimates intelligence quotient; Diagnostic test: Clinical tests of ASD; Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2); Other: Electroencephalography (EEG) with auditory or vibrotactile stimuli; Two paradigms will be used: an auditory frequency tagging paradigm with interspersed pitch oddballs and a classical sensory gating paradigm with either vibrotactile stimuli or auditory clicks.
Children with Attention-Deficit Hyperactivity Disorder; Children with a confirmed diagnosis of attention-deficit hyperactivity disorder made by a qualified psychiatrist.	Behavioral: Discrimination Acuity test; Estimating the just-noticeable difference of auditory loudness and vibrotactile displacement to fit a psychometric function for each modality with parameters: threshold, slope, sensitivity, and response criterion.; Diagnostic test: Transiently Evoked Otoacoustic Emission; Examination of integrity of outer hair cells in the inner ear; with and without contralateral suppression.; Other: Questionnaires; Caregiver questionnaires send to parents online to acquire demographic information Autism Quotient (AQ), Child Behavior Checklist (CBCL6-16), Sensory Profile 2 (SP-2).; Behavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V); Estimates intelligence quotient; Other: Electroencephalography (EEG) with auditory or vibrotactile stimuli; Two paradigms will be used: an auditory frequency tagging paradigm with interspersed pitch oddballs and a classical sensory gating paradigm with either vibrotactile stimuli or auditory clicks.; Diagnostic test: Clinical tests of ADHD; ADHD-Rating Scale (ADHD-RS)
Neurotypical children; Children without a known or presumed psychiatric diagnosis.	Behavioral: Discrimination Acuity test; Estimating the just-noticeable difference of auditory loudness and vibrotactile displacement to fit a psychometric function for each modality with parameters: threshold, slope, sensitivity, and response criterion.; Diagnostic test: Transiently Evoked Otoacoustic Emission; Examination of integrity of outer hair cells in the inner ear; with and without contralateral suppression.; Other: Questionnaires; Caregiver questionnaires send to parents online to acquire demographic information Autism Quotient (AQ), Child Behavior Checklist (CBCL6-16), Sensory Profile 2 (SP-2).; Behavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V); Estimates intelligence quotient; Other: Electroencephalography (EEG) with auditory or vibrotactile stimuli; Two paradigms will be used: an auditory frequency tagging paradigm with interspersed pitch oddballs and a classical sensory gating paradigm with either vibrotactile stimuli or auditory clicks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Profile 2	Caregiver questionnaire to assess sensory anomalies	8 minutes, answered within 1 month of the experimental session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)	General intelligence quotient	1 hour 15 minutes, conducted within 1 year of the experimental session
Autism Quotient (AQ, child version)	Questionnaire addressing autistic traits	8 minutes, answered within 1 month of the experimental session
Childhood Behavioral Checklist (CBCL 6-16)	Questionnaire addressing various behaviors relevant to DSM-V	15 minutes, answered within 1 month of the experimental session
ADHD-Ration Scale (ADHD-RS)	Questionnaire addressing behaviors related to severity of ADHD symptoms	15 minutes, conducted within 1 year of the experimental session
Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)	Questionnaire addressing behaviors related to severity of ASD symptoms	1 hour, conducted within 1 year of the experimental session
Use of pharmacotherapy	Use of pharmacotherapy	At time of experimental session
Transiently Evoked Otoacoustic Emission (TEOAE)	Cochlear energy produced during the processing of a click sound using Titan (Interacoustics A/S, Denmark) measured in decibel (dB) above the noise floor (i.e., signal-to-noise ratio).	2 minutes, during experimental session
Contralateral suppression of TEOAE	The suppression effect on the TEOAE during binaural stimulation. Here, constant contralateral broadband pink noise is applied simultaneous to a ipsilateral TEOAE measurement. Thus, the measurement is similar to a TEOAE but here the outcome measure is the difference score (i.e., suppression effect) of with/without contralateral stimulation.	2 minutes, during experimental session
Categorical Loudness Scale	Identifying quiet threshold, loudness discomfort level, and a grading of sound intensities between (quiet threshold, soft, comfortable, loud, loudness discomfort level).	5 minutes, during experimental session
Auditory Loudness Discrimination Acuity	The just-noticeable difference (JND) from a reference tone intensity (65 decibel sound pressure level (dBSPL), 250 ms, 1000 Hz at interval one) to a test tone (amplitude increase between 0-15 dBSPL at interval two). The unit of JND is the change in dBSLP relative to the reference tone (ΔdBSLP).	5 minutes, during experimental session
Vibrotactile Displacement Discrimination Acuity	The just-noticeable difference (JND) from a reference displacement intensity (160 µm, 250 ms, 230 Hz at interval one) to a test tone (amplitude increase between 0-640 µm at interval two). The unit of JND is the change in µm relative to the reference displacement (Δµm).	5 minutes, during experimental session
Electroencephalography, sensory gating paradigm with auditory and vibrotactile stimulation	Gating/suppression of components in the event-related potential (ERP), beta-band power, and inter-trial phase coherence during stimulation.	30 minutes, during experimental session
Electroencephalography, frequency tagging with pitch oddball (two conditions)	Difference scores for half semi-tone oddball and four semi-tone oddball in pitch deviation.; Frequency domain amplitude for the standard and oddball (1.6 and 8 Hz); Narrow-band filtered EEG amplitudes (1-17 Hz)	7 minutes, during experimental session

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: Université Catholique de Louvain; Colorado State University; North Denmark Region

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Estimated): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder
• Other Study ID Numbers: N-20200091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No