Neural Mechanisms of Sensory Processing Anomalies

Autism Spectrum Disorder Clinical Trial

Official title:

Understanding the Neural Mechanism Behind Sensory Processing Anomalies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234033
• Other study ID #: N-20200091
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: Aalborg University
• Contact: Sabata Gervasio
• Phone: 9940 8820
• Email: saba[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Autism Spectrum Disorder
• Sensory Processing Disorder

Intervention

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.

Diagnostic Test:
• Clinical tests of ADHD
ADHD-Rating Scale (ADHD-RS)

Locations

Country	Name	City	State
Denmark	Health Science and Technology	Aalborg	Nordjylland

Sponsors (4)

Lead Sponsor	Collaborator
Aalborg University	Colorado State University, North Denmark Region, Université Catholique de Louvain

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory Profile 2	Caregiver questionnaire to assess sensory anomalies	8 minutes, answered within 1 month of the experimental session
Secondary	Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)	General intelligence quotient	1 hour 15 minutes, conducted within 1 year of the experimental session
Secondary	Autism Quotient (AQ, child version)	Questionnaire addressing autistic traits	8 minutes, answered within 1 month of the experimental session
Secondary	Childhood Behavioral Checklist (CBCL 6-16)	Questionnaire addressing various behaviors relevant to DSM-V	15 minutes, answered within 1 month of the experimental session
Secondary	ADHD-Ration Scale (ADHD-RS)	Questionnaire addressing behaviors related to severity of ADHD symptoms	15 minutes, conducted within 1 year of the experimental session
Secondary	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
Secondary	Use of pharmacotherapy	Use of pharmacotherapy	At time of experimental session
Secondary	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
Secondary	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
Secondary	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
Secondary	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 (?dBSLP).	5 minutes, during experimental session
Secondary	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 (?µm).	5 minutes, during experimental session
Secondary	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
Secondary	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