Neural Mechanisms of Sensory Processing Anomalies

Recruiting

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

• Registration Number: NCT06234033
• Lead Sponsor: Aalborg University

Brief Summary

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.

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 Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-12-07
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-01-31
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with Autism Spectrum Disorder	Questionnaires	Children with a confirmed diagnosis of autism spectrum disorder made by a qualified psychiatrist.
Children with Attention-Deficit Hyperactivity Disorder	Transiently Evoked Otoacoustic Emission	Children with a confirmed diagnosis of attention-deficit hyperactivity disorder made by a qualified psychiatrist.
Neurotypical children	Discrimination Acuity test	Children without a known or presumed psychiatric diagnosis.
Children with Autism Spectrum Disorder	Discrimination Acuity test	Children with a confirmed diagnosis of autism spectrum disorder made by a qualified psychiatrist.
Children with Attention-Deficit Hyperactivity Disorder	Questionnaires	Children with a confirmed diagnosis of attention-deficit hyperactivity disorder made by a qualified psychiatrist.
Neurotypical children	Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)	Children without a known or presumed psychiatric diagnosis.
Children with Autism Spectrum Disorder	Transiently Evoked Otoacoustic Emission	Children with a confirmed diagnosis of autism spectrum disorder made by a qualified psychiatrist.
Children with Attention-Deficit Hyperactivity Disorder	Discrimination Acuity test	Children with a confirmed diagnosis of attention-deficit hyperactivity disorder made by a qualified psychiatrist.
Children with Attention-Deficit Hyperactivity Disorder	Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)	Children with a confirmed diagnosis of attention-deficit hyperactivity disorder made by a qualified psychiatrist.
Children with Attention-Deficit Hyperactivity Disorder	Electroencephalography (EEG) with auditory or vibrotactile stimuli	Children with a confirmed diagnosis of attention-deficit hyperactivity disorder made by a qualified psychiatrist.
Neurotypical children	Transiently Evoked Otoacoustic Emission	Children without a known or presumed psychiatric diagnosis.
Children with Autism Spectrum Disorder	Electroencephalography (EEG) with auditory or vibrotactile stimuli	Children with a confirmed diagnosis of autism spectrum disorder made by a qualified psychiatrist.
Neurotypical children	Questionnaires	Children without a known or presumed psychiatric diagnosis.
Neurotypical children	Electroencephalography (EEG) with auditory or vibrotactile stimuli	Children without a known or presumed psychiatric diagnosis.
Children with Autism Spectrum Disorder	Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)	Children with a confirmed diagnosis of autism spectrum disorder made by a qualified psychiatrist.
Children with Autism Spectrum Disorder	Clinical tests of ASD	Children with a confirmed diagnosis of autism spectrum disorder made by a qualified psychiatrist.
Children with Attention-Deficit Hyperactivity Disorder	Clinical tests of ADHD	Children with a confirmed diagnosis of attention-deficit hyperactivity disorder made by a qualified psychiatrist.

Primary Outcome Measures

Name	Time	Method
Sensory Profile 2	8 minutes, answered within 1 month of the experimental session	Caregiver questionnaire to assess sensory anomalies

Secondary Outcome Measures

Name	Time	Method
Vibrotactile Displacement Discrimination Acuity	5 minutes, during experimental session	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).
Autism Quotient (AQ, child version)	8 minutes, answered within 1 month of the experimental session	Questionnaire addressing autistic traits
Transiently Evoked Otoacoustic Emission (TEOAE)	2 minutes, during experimental session	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).
ADHD-Ration Scale (ADHD-RS)	15 minutes, conducted within 1 year of the experimental session	Questionnaire addressing behaviors related to severity of ADHD symptoms
Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)	1 hour, conducted within 1 year of the experimental session	Questionnaire addressing behaviors related to severity of ASD symptoms
Auditory Loudness Discrimination Acuity	5 minutes, during experimental session	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).
Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)	1 hour 15 minutes, conducted within 1 year of the experimental session	General intelligence quotient
Childhood Behavioral Checklist (CBCL 6-16)	15 minutes, answered within 1 month of the experimental session	Questionnaire addressing various behaviors relevant to DSM-V
Use of pharmacotherapy	At time of experimental session	Use of pharmacotherapy
Contralateral suppression of TEOAE	2 minutes, during experimental session	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.
Categorical Loudness Scale	5 minutes, during experimental session	Identifying quiet threshold, loudness discomfort level, and a grading of sound intensities between (quiet threshold, soft, comfortable, loud, loudness discomfort level).
Electroencephalography, sensory gating paradigm with auditory and vibrotactile stimulation	30 minutes, during experimental session	Gating/suppression of components in the event-related potential (ERP), beta-band power, and inter-trial phase coherence during stimulation.
Electroencephalography, frequency tagging with pitch oddball (two conditions)	7 minutes, during experimental session	Difference scores for half semi-tone oddball and four semi-tone oddball in pitch deviation.; 1. Frequency domain amplitude for the standard and oddball (1.6 and 8 Hz); 2. Narrow-band filtered EEG amplitudes (1-17 Hz)

Trial Locations

Locations (1)

Health Science and Technology; 🇩🇰 Aalborg, Nordjylland, Denmark