Assessing Neurophysiological and Cognitive Function in School Children

Pediatric ALL Clinical Trial

— WIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06209528
• Other study ID #: I-0028
• Status: Not yet recruiting
• Start date: February 15, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Life University
• Contact: Austin Garlinghouse
• Phone: 770-426-2639
• Email: research.studies[@]life.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 1, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric ALL

Locations

Country	Name	City	State
United States	Chippewa Falls Area Unified School District	Chippewa Falls	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Life University	New Zealand College of Chiropractic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Total number of subjects enrolled	Recruitment period (1 week)
Primary	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)
Primary	Participant compliance	Proportion of participants able to comply with the instructions for a given task	Study period (2 school weeks)
Primary	Protocol efficiency	Average time to completion for both of the 1-day assessment sessions	1 school week
Primary	Data fidelity	Proportion of acquisitions for a given task with data suitable for subsequent analysis	Study period (2 school weeks)