Pediatric ALLWISNCT06209528
Assessing Neurophysiological and Cognitive Function in School Children
An observational study of Pediatric ALL, run by Life University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric ALL
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to 28 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: School-age children
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Chippewa Falls Area Unified School District
Chippewa Falls, Wisconsin, 54729-1923
About this study
Official title: Assessing Neurophysiological Function, Cognitive Function, and Health-related Quality of Life in School Children: a Feasibility Study
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).
Read the 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.
- Conditions
- Pediatric ALL
- Keywords
- pediatrics, EEG, cognition, autonomic nervous system, HRV
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| School-aged children | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Total number of subjects enrolled
Measured: 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
Measured: Study period (2 school weeks)
Participant compliance
Proportion of participants able to comply with the instructions for a given task
Measured: Study period (2 school weeks)
Protocol efficiency
Average time to completion for both of the 1-day assessment sessions
Measured: 1 school week
Data fidelity
Proportion of acquisitions for a given task with data suitable for subsequent analysis
Measured: Study period (2 school weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start26 Mar 2024
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Collaborators
- New Zealand College of Chiropractic
- Responsible party
- Sponsor
- Investigators
- Tyson Perez, PhD, Principal investigator, Life University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209528
- Sponsor's protocol ID
- I-0028
- Acronym
- WIS
- Status last verified
- Aug 2024
- First submitted
- 8 Jan 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Neurophysiological Function, Cognitive Function, and Health-related Quality of Life in School Children: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06209528
- Acronym / sponsor ID
- WIS / I-0028
- Conditions
- Pediatric ALL
- Keywords
- pediatrics, EEG, cognition, autonomic nervous system, HRV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Collaborators
- New Zealand College of Chiropractic
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| School-aged children | – | –No intervention |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- School-age children
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recruitment rate
Time frame: Recruitment period (1 week)
Total number of subjects enrolled
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
Participant compliance
Time frame: Study period (2 school weeks)
Proportion of participants able to comply with the instructions for a given task
Protocol efficiency
Time frame: 1 school week
Average time to completion for both of the 1-day assessment sessions
Data fidelity
Time frame: Study period (2 school weeks)
Proportion of acquisitions for a given task with data suitable for subsequent analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyson Perez, PhD principal investigator
Life University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric ALL, run by Life University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Recruitment period (1 week)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.