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Completed

NCT Number: NCT06209528

Assessing Neurophysiological and Cognitive Function in School Children

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).

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chippewa Falls Area Unified School District

Chippewa Falls, Wisconsin, 54729-1923, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recruitment rate

    Time frame: Recruitment period (1 week)

    Total number of subjects enrolled

  2. Protocol tolerability

    Time frame: Study period (2 school weeks)

    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

  3. Participant compliance

    Time frame: Study period (2 school weeks)

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

  4. Protocol efficiency

    Time frame: 1 school week

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

  5. Data fidelity

    Time frame: Study period (2 school weeks)

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

Sponsors and collaborators

Lead sponsor

Life University

Other

Collaborators

  • New Zealand College of Chiropractic

Registry information

Official study title

Assessing Neurophysiological Function, Cognitive Function, and Health-related Quality of Life in School Children: a Feasibility Study

Acronym: WIS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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