Normative QEEG/ERP Data for Healthy Volunteers

March 27, 2024 updated by: Neuronetrix, Inc.

Establishing Normative Values for Event Related Potentials (ERPs) and Quantitative EEG (QEEG) in Adult, Healthy Volunteers

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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40214
        • Recruiting
        • Cognision
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marco Cecchi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Approximately 80 male and female participants between 20 and 59 years of age (inclusive) who meet all eligibility requirements as specified, will participate in this study.

Description

Inclusion Criteria:

  1. Male and female volunteers 20-59 years of age, inclusive.
  2. Willingness and ability to provide 1 form of identification with picture.
  3. Willingness and ability to provide to understand the requirements of the study, provide written informed consent, and abide by the study procedures.
  4. Fluency in English, even if English is not the primary language.
  5. Ability to tolerate the electrode cap for the duration of the testing session.
  6. Subject has not been enrolled or actively participating in another clinical study 4 weeks prior to testing.

Exclusion Criteria:

  1. History of neurological and/or psychiatric disorders:

    • Diseases of the Dementia type (i.e. Alzheimer's Disease, Vascular Dementia, Parkinson's Disease Dementia etc.)
    • Epileptic seizures
    • Bipolar Disorder
    • Autism Spectrum Disorder
    • Depression
    • Brain tumor(s)
    • Multiple Sclerosis
    • Schizophrenia or Schizoaffective Disorder
    • Stroke (ischemic or hemorrhagic)
    • Traumatic Brain Injury
    • Current Drug or Alcohol Abuse
  2. Diagnosis with HIV/AIDS
  3. Inability to detect a 1000Hz tone at 40dB in either ear.
  4. Recent (24 hours) use of medications known to affect QEEG/ERP (cannabinoids, sleep aides, benzodiazepines, opiates/opioids, amphetamines, or barbiturates).
  5. Recent (day of study) use of energy drinks, including pre-workout drinks and over the counter energy supplements and nootropics.
  6. Caffeine, alcohol, or products containing nicotine within 1 hour of testing.
  7. Known allergy to latex.
  8. Any impairment, activity, or situation that, in the judgment of the study Sponsor, would prevent satisfactory completion of the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1 (n=10)
Gender: Male Age: 20-29
Cohort 2 (n=10)
Gender: Female Age: 20-29
Cohort 3 (n=10)
Gender: Male Age: 30-39
Cohort 4 (n=10)
Gender: Female Age: 30-39
Cohort 5 (n=10)
Gender: Male Age: 40-49
Cohort 6 (n=10)
Gender: Female Age: 40-49
Cohort 7 (n=10)
Gender: Male Age: 50-59
Cohort 8 (n=10)
Gender: Female Age: 50-59

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amplitude for parameters from the Active, Auditory Oddball ERP test.
Time Frame: Day 1

Amplitude (in microvolts) for the following parameters from the Active, Oddball ERP test:

  1. P50
  2. N100
  3. P200
  4. N200
  5. P3b
Day 1
Latency for parameters from the Active, Auditory Oddball ERP test.
Time Frame: Day 1

Latency (in milliseconds) for the following parameters from the Active, Auditory Oddball ERP test:

  1. P50
  2. N100
  3. P200
  4. N200
  5. P3b
Day 1
Task accuracy from the behavioral response during the Active, Auditory Oddball ERP test.
Time Frame: Day 1
Change in task accuracy as a percentage of correct behavioral responses during the Active, Auditory Oddball ERP test.
Day 1
Reaction Time from the behavioral response during the Active, Auditory Oddball ERP test.
Time Frame: Day 1
Median reaction time for the correct behavioral responses measured in milliseconds during the Active, Auditory Oddball ERP test.
Day 1
QEEG measures from the Vigilance EEG
Time Frame: Day 1

Changes in Absolute Power (measured in µv2/Hz) for the following Pharmaco-EEG parameters:

  • Delta power
  • Theta power
  • Alpha power
  • Beta power
  • Gamma power
  • Total power
Day 1
QEEG measures from the Eyes-closed Resting EEG
Time Frame: Day 1

Changes in Absolute Power (measured in µv2/Hz) for the following Pharmaco-EEG parameters:

  • Delta power
  • Theta power
  • Alpha power
  • Beta power
  • Gamma power
  • Total power
  • Changes in frequency (measured in Hz) for peak alpha
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuronetrix, Inc.

Investigators

  • Principal Investigator: Marco Cecchi, PhD, Cognision

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SRP-1951

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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