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Clinical Trials/NCT06234033
NCT06234033
Recruiting
N/A

Understanding the Neural Mechanism Behind Sensory Processing Anomalies

Aalborg University1 site in 1 country75 target enrollmentNovember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Aalborg University
Enrollment
75
Locations
1
Primary Endpoint
Sensory Profile 2
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
October 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Aalborg University
Responsible Party
Principal Investigator
Principal Investigator

Daniel Skak Mazhari-Jensen

PhD-Fellow

Aalborg University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Sensory Profile 2

Time Frame: 8 minutes, answered within 1 month of the experimental session

Caregiver questionnaire to assess sensory anomalies

Secondary Outcomes

  • Vibrotactile Displacement Discrimination Acuity(5 minutes, during experimental session)
  • Autism Quotient (AQ, child version)(8 minutes, answered within 1 month of the experimental session)
  • Transiently Evoked Otoacoustic Emission (TEOAE)(2 minutes, during experimental session)
  • ADHD-Ration Scale (ADHD-RS)(15 minutes, conducted within 1 year of the experimental session)
  • Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)(1 hour, conducted within 1 year of the experimental session)
  • Auditory Loudness Discrimination Acuity(5 minutes, during experimental session)
  • Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)(1 hour 15 minutes, conducted within 1 year of the experimental session)
  • Childhood Behavioral Checklist (CBCL 6-16)(15 minutes, answered within 1 month of the experimental session)
  • Use of pharmacotherapy(At time of experimental session)
  • Contralateral suppression of TEOAE(2 minutes, during experimental session)
  • Categorical Loudness Scale(5 minutes, during experimental session)
  • Electroencephalography, sensory gating paradigm with auditory and vibrotactile stimulation(30 minutes, during experimental session)
  • Electroencephalography, frequency tagging with pitch oddball (two conditions)(7 minutes, during experimental session)

Study Sites (1)

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