Clinical trial NCT06209528: Assessing Neurophysiological and Cognitive Function in School Children
Official title: Assessing Neurophysiological Function, Cognitive Function, and Health-related Quality of Life in School Children: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric ALL
Keywords: pediatrics
EEG
cognition
autonomic nervous system
HRV
Lead sponsor: Life University
Sponsor class: OTHER
Collaborators: name: New Zealand College of Chiropractic
First posted: 2024-01-17
Enrollment: 17
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: School-age children

Brief summary: This trial will investigate the feasibility of implementing our novel assessment battery in a neurodiverse pediatric population. More specifically, we want to assess our processes and procedures with respect to 1) recruitment rate (i.e., efficiency of our recruitment methods), 2) tolerability (i.e., proportion of participants able to wear the hardware without difficulty), 3) compliance (i.e., proportion of participants able to complete each task as instructed), 4) efficiency (i.e., time to completion of the test battery), and 5) data fidelity (i.e., proportion of test acquisitions with data suitable for subsequent analyses).

Detailed description: The total estimated time requirement for this study is \~60 minutes (i.e., two \~30-minute sessions) and wearing a FitBit for 7 days.

Per their normal and customary procedures, Drs. Amanda and Lona will send a cover letter home to the parent(s)/guardian(s) of their patients introducing the study along with the informed consent (IC) form. Parent(s)/guardian(s) will be asked to indicate their level of interest on the letter and return it (along with the IC, if applicable) to the school. Parents/guardians who indicate that they have additional queries will be contacted by a member of our research staff via the parent's/guardian's preferred method (i.e., phone, text, and/or email). A signed IC will be required prior to enrolling any student in the study.

Up to 20 students (ages 5-17) will be tested over the course of 1 week.

This study will be conducted in designated testing rooms at participating schools within the Chippewa Falls district (Wisconsin, USA). A researcher will sit down with each student and review the age-appropriate informed assent (IA) form. Even if their parent(s)/guardian(s) would like them to participate, students must acknowledge their willingness to participate verbally (e.g., "yes I would like to do the study") and/or physically (e.g., nod their head \& give a thumbs up) and sign the IA form to be enrolled in the study.

The primary aims of this trial are to investigate the feasibility of implementing our novel assessment battery with a neurodiverse pediatric population. More specifically, we want to assess our processes and procedures with respect to 1) recruitment rate (i.e., number of subjects recruited within the 1 month recruitment window), 2) tolerability (i.e., proportion of participants able to wear the hardware without difficulty), 3) compliance (i.e., proportion of participants able to complete each task as instructed), 4) efficiency (i.e., time to completion of the test battery), and 5) data fidelity (i.e., proportion of test acquisitions with data suitable for subsequent analyses). This feasibility trial is intended inform a future cluster randomized controlled trial (RCT) assessing the effects of chiropractic care on a neurodiverse pediatric population.

Eligibility criteria: Inclusion Criteria:

* 5-17 years old
* Student of the Chippewa Falls school district
* Parent(s)/Guardian(s) provide signed informed consent
* Child able to provide signed informed assent \& acknowledge desire to participate verbally (e.g., "Yes, I want to do the study") and/or physically (e.g., nods head \& gives thumbs up).

Exclusion Criteria:

* Unable to perform assessments due to movement limitations (e.g., confined to a wheelchair)
* Unable to perform the assessments due to contraindications (e.g., has a disorder that causes fainting during postural changes such as POTS or orthostatic hypotension)
* Pacemaker or known heart condition that influences the electrical function of the heart
* Deemed to be at "high risk" of suicide per the C-SSRS

Primary outcomes:
measure: Recruitment rate
timeFrame: Recruitment period (1 week)
measure: Protocol tolerability
timeFrame: Study period (2 school weeks)
measure: Participant compliance
timeFrame: Study period (2 school weeks)
measure: Protocol efficiency
timeFrame: 1 school week
measure: Data fidelity
timeFrame: Study period (2 school weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Chippewa Falls
country: United States
facility: Chippewa Falls Area Unified School District
state: Wisconsin
Study officials:
affiliation: Life University
name: Tyson Perez, PhD
role: PRINCIPAL_INVESTIGATOR
References: