Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
Study NCT ID:
NCT05869032
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2023-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Normative QEEG/ERP Data for Healthy Volunteers
Sponsor:
Neuronetrix, Inc.
Organization:
Study Overview
Official Title:
Establishing Normative Values for Event Related Potentials (ERPs) and Quantitative EEG (QEEG) in Adult, Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many scientific papers have reported that ERP and QEEG biomarkers can be useful in the evaluation of neurological and psychiatric disorders. A study previously conducted with the COGNISION® system has shown how data collected with the system could help detect cognitive deficits in elderly individuals with probable early Alzheimer's disease (Cecchi et al., 2015). Furthermore, normative ranges for ERP and QEEG parameters are sensitive to subject age (see for example van Dinteren et al., 2014). This study will use advanced EEG techniques to measure brain function among healthy adults ages 20 through 59 to use as reference data to compare against individuals that suffer from neurological and psychiatric disorders. QEEG and ERP parameters from the current study will compliment previously collected normative data in healthy subjects 60 years of age and older (Cecchi et al., 2015).
Detailed Description:
This is a cross-sectional, observational study in healthy, adult volunteers. This study will use advanced EEG techniques to measure brain function among healthy adults ages 20 through 59 to use as reference data to compare against individuals that suffer from neurological and psychiatric disorders. ERP and QEEG parameters from the current study will complement previously collected normative data in healthy subjects 60 years of age and older (Cecchi et al., 2015).
Study subject population will be stratified by age and gender as detailed in protocol. All assessments will be performed during a single visit that will take up to 90 min. Potential participants will be recruited through local advertising, and participants are free to withdraw from the study at any time. Candidates potentially interested in the study will be explained the purpose of the study, and possible risks and benefits. Those individuals who choose to sign the informed consent will then be screened to ascertain that they meet eligibility. Study subjects that meet inclusion/exclusion criteria will be tested to collect ERP and QEEG parameters using the FDA-cleared COGNISION® system. Data from the ERP and EEG tests will be used to generate ERP and QEEG parameters from the study.
The ERP/EEG testing session will be about 40 min long. Tests administered will include an active, Auditory Oddball ERP test, a Vigilance EEG test, and an Eyes-closed Resting EEG test. A participant may be withdrawn from the study if: 1) The participant fails to meet inclusion/exclusion criteria or 2) The participant or the study Sponsor feels that it is not in the participant's best interest to continue. Upon withdrawal, no further assessments will be performed on the participant and no additional participation will be required of the participant. Additional participants will be recruited to replace withdrawn study subjects, until the study reaches full enrollment of 80 completers.
Study subject population will be stratified by age and gender as detailed in protocol. All assessments will be performed during a single visit that will take up to 90 min. Potential participants will be recruited through local advertising, and participants are free to withdraw from the study at any time. Candidates potentially interested in the study will be explained the purpose of the study, and possible risks and benefits. Those individuals who choose to sign the informed consent will then be screened to ascertain that they meet eligibility. Study subjects that meet inclusion/exclusion criteria will be tested to collect ERP and QEEG parameters using the FDA-cleared COGNISION® system. Data from the ERP and EEG tests will be used to generate ERP and QEEG parameters from the study.
The ERP/EEG testing session will be about 40 min long. Tests administered will include an active, Auditory Oddball ERP test, a Vigilance EEG test, and an Eyes-closed Resting EEG test. A participant may be withdrawn from the study if: 1) The participant fails to meet inclusion/exclusion criteria or 2) The participant or the study Sponsor feels that it is not in the participant's best interest to continue. Upon withdrawal, no further assessments will be performed on the participant and no additional participation will be required of the participant. Additional participants will be recruited to replace withdrawn study subjects, until the study reaches full enrollment of 80 completers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: