Assessing Neurophysiological and Cognitive Function in School Children

NCT06209528 | Completed

• 1 other identifier: I-0028
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

Pediatric ALL

Keywords

pediatrics; EEG; cognition; autonomic nervous system; HRV

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Total number of subjects enrolled

  Recruitment period (1 week)

• Protocol tolerability

  Proportion of participants able to tolerate wearing a given piece of acquisition hardware (i.e., EEG cap, ECG sensors, FitBit) for the duration of the study period

  Study period (2 school weeks)

• Participant compliance

  Proportion of participants able to comply with the instructions for a given task

  Study period (2 school weeks)

• Protocol efficiency

  Average time to completion for both of the 1-day assessment sessions

  1 school week

• Data fidelity

  Proportion of acquisitions for a given task with data suitable for subsequent analysis

  Study period (2 school weeks)

Study Arms (1)

School-aged children

No intervention

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

School-age children

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Life University: lead
• New Zealand College of Chiropractic: collaborator

Study Sites (1)

Chippewa Falls Area Unified School District

Chippewa Falls, Wisconsin, 54729-1923, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Tyson Perez, PhD

  Life University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 17, 2024
• Study Start: March 26, 2024
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)