HealthyNCT05869032
Normative QEEG/ERP Data for Healthy Volunteers
An observational study of Healthy, run by Neuronetrix, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 30 Sep 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 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Male and female volunteers 20-59 years of age, inclusive.
- Willingness and ability to provide 1 form of identification with picture.
- Willingness and ability to provide to understand the requirements of the study, provide written informed consent, and abide by the study procedures.
- Fluency in English, even if English is not the primary language.
- Ability to tolerate the electrode cap for the duration of the testing session.
- Subject has not been enrolled or actively participating in another clinical study 4 weeks prior to testing.
Who cannot join
- 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
Show all 19Show fewer
- Brain tumor(s)
- Multiple Sclerosis
- Schizophrenia or Schizoaffective Disorder
- Stroke (ischemic or hemorrhagic)
- Traumatic Brain Injury
- Current Drug or Alcohol Abuse
- Diagnosis with HIV/AIDS
- Inability to detect a 1000Hz tone at 40dB in either ear.
- Recent (24 hours) use of medications known to affect QEEG/ERP (cannabinoids, sleep aides, benzodiazepines, opiates/opioids, amphetamines, or barbiturates).
- Recent (day of study) use of energy drinks, including pre-workout drinks and over the counter energy supplements and nootropics.
- Caffeine, alcohol, or products containing nicotine within 1 hour of testing.
- Known allergy to latex.
- Any impairment, activity, or situation that, in the judgment of the study Sponsor, would prevent satisfactory completion of the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cognision
Louisville, Kentucky, 40214
Vickie M Tang, 502-294-5109, vtang@cognision.com
John T Jones, (502) 561-9040 ext. 7002, jjones@cognision.com
About this study
Official title: 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).
Read the 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.
- Conditions
- Healthy
- Keywords
- Brain Function, Normative Values, Event-Related Potentials (ERP), Quantitative Electroencephalography (QEEG), Cognitive Processing, Frequency, Amplitude, Brain Activity, Electroencephalogram, Neural Processing
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Amplitude for parameters from the Active, Auditory Oddball ERP test.
Amplitude (in microvolts) for the following parameters from the Active, Oddball ERP test:
- P50
- N100
- P200
- N200
- P3b
Measured: Day 1
Latency for parameters from the Active, Auditory Oddball ERP test.
Latency (in milliseconds) for the following parameters from the Active, Auditory Oddball ERP test:
- P50
- N100
- P200
- N200
- P3b
Measured: Day 1
Task accuracy from the behavioral response during the Active, Auditory Oddball ERP test.
Change in task accuracy as a percentage of correct behavioral responses during the Active, Auditory Oddball ERP test.
Measured: Day 1
Reaction Time from the behavioral response during the Active, Auditory Oddball ERP test.
Median reaction time for the correct behavioral responses measured in milliseconds during the Active, Auditory Oddball ERP test.
Measured: Day 1
QEEG measures from the Vigilance EEG
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
Measured: Day 1
QEEG measures from the Eyes-closed Resting EEG
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start22 May 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuronetrix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Cecchi, PhD, Principal investigator, COGNISION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869032
- Sponsor's protocol ID
- SRP-1951
- Status last verified
- Mar 2024
- First submitted
- 11 May 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cecchi M, Adachi M, Basile A, Buhl DL, Chadchankar H, Christensen S, Christian E, Doherty J, Fadem KC, Farley B, Forman MS, Honda S, Johannesen J, Kinon BJ, Klamer D, Marino MJ, Missling C, O'Donnell P, Piser T, Puryear CB, Quirk MC, Rotte M, Sanchez C, Smith DG, Uslaner JM, Javitt DC, Keefe RSE, Mathalon D, Potter WZ, Walling DP, Ereshefsky L. Validation of a suite of ERP and QEEG biomarkers in a pre-competitive, industry-led study in subjects with schizophrenia and healthy volunteers. Schizophr Res. 2023 Apr;254:178-189. doi: 10.1016/j.schres.2023.02.018. Epub 2023 Mar 13.
PubMed 36921403Cecchi M, Moore DK, Sadowsky CH, Solomon PR, Doraiswamy PM, Smith CD, Jicha GA, Budson AE, Arnold SE, Fadem KC. A clinical trial to validate event-related potential markers of Alzheimer's disease in outpatient settings. Alzheimers Dement (Amst). 2015 Oct 2;1(4):387-94. doi: 10.1016/j.dadm.2015.08.004. eCollection 2015 Dec.
PubMed 27239520Haller, M., Donoghue, T., Peterson, E., Varma, P., Sebastian, P., Gao, R., … Voytek, B. (2018). Parameterizing neural power spectra. BioRxiv, 299859. https://doi.org/10.1101/299859
Jobert M, Wilson FJ, Ruigt GS, Brunovsky M, Prichep LS, Drinkenburg WH; IPEG Pharmaco-EEG Guidelines Committee. Guidelines for the recording and evaluation of pharmaco-EEG data in man: the International Pharmaco-EEG Society (IPEG). Neuropsychobiology. 2012;66(4):201-20. doi: 10.1159/000343478. Epub 2012 Oct 12.
PubMed 23075830van Dinteren R, Arns M, Jongsma ML, Kessels RP. P300 development across the lifespan: a systematic review and meta-analysis. PLoS One. 2014 Feb 13;9(2):e87347. doi: 10.1371/journal.pone.0087347. eCollection 2014.
PubMed 24551055
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Normative Values for Event Related Potentials (ERPs) and Quantitative EEG (QEEG) in Adult, Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05869032
- Acronym / sponsor ID
- SRP-1951
- Conditions
- Healthy
- Keywords
- Brain Function, Normative Values, Event-Related Potentials (ERP), Quantitative Electroencephalography (QEEG), Cognitive Processing, Frequency, Amplitude, Brain Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Neuronetrix, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 22 May 2023 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- Male and female volunteers 20-59 years of age, inclusive.
- Willingness and ability to provide 1 form of identification with picture.
- Willingness and ability to provide to understand the requirements of the study, provide written informed consent, and abide by the study procedures.
- Fluency in English, even if English is not the primary language.
- Ability to tolerate the electrode cap for the duration of the testing session.
Key exclusion criteria (19 listed)
- History of neurological and/or psychiatric disorders:
- Diagnosis with HIV/AIDS
- Inability to detect a 1000Hz tone at 40dB in either ear.
- Recent (24 hours) use of medications known to affect QEEG/ERP (cannabinoids, sleep aides, benzodiazepines, opiates/opioids, amphetamines, or barbiturates).
- Recent (day of study) use of energy drinks, including pre-workout drinks and over the counter energy supplements and nootropics.
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
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
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
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.
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.
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Results publication: PubMed 36921403Cecchi M, Adachi M, Basile A, Buhl DL, Chadchankar H, Christensen S, Christian E, Doherty J, Fadem KC, Farley B, Forman MS, Honda S, Johannesen J, Kinon BJ, Klamer D, Marino MJ, Missling C, O'Donnell P, Piser T, Puryear CB, Quirk MC, Rotte M, Sanchez C, Smith DG, Uslaner JM, Javitt DC, Keefe RSE, Mathalon D, Potter WZ, Walling DP, Ereshefsky L. Validation of a suite of ERP and QEEG biomarkers in a pre-competitive, industry-led study in subjects with schizophrenia and healthy volunteers. Schizophr Res. 2023 Apr;254:178-189. doi: 10.1016/j.schres.2023.02.018. Epub 2023 Mar 13.
- Results publication: PubMed 27239520Cecchi M, Moore DK, Sadowsky CH, Solomon PR, Doraiswamy PM, Smith CD, Jicha GA, Budson AE, Arnold SE, Fadem KC. A clinical trial to validate event-related potential markers of Alzheimer's disease in outpatient settings. Alzheimers Dement (Amst). 2015 Oct 2;1(4):387-94. doi: 10.1016/j.dadm.2015.08.004. eCollection 2015 Dec.
- Results publicationHaller, M., Donoghue, T., Peterson, E., Varma, P., Sebastian, P., Gao, R., … Voytek, B. (2018). Parameterizing neural power spectra. BioRxiv, 299859. https://doi.org/10.1101/299859
- Results publication: PubMed 23075830Jobert M, Wilson FJ, Ruigt GS, Brunovsky M, Prichep LS, Drinkenburg WH; IPEG Pharmaco-EEG Guidelines Committee. Guidelines for the recording and evaluation of pharmaco-EEG data in man: the International Pharmaco-EEG Society (IPEG). Neuropsychobiology. 2012;66(4):201-20. doi: 10.1159/000343478. Epub 2012 Oct 12.
- Results publication: PubMed 24551055van Dinteren R, Arns M, Jongsma ML, Kessels RP. P300 development across the lifespan: a systematic review and meta-analysis. PLoS One. 2014 Feb 13;9(2):e87347. doi: 10.1371/journal.pone.0087347. eCollection 2014.
- Individual participant dataSharing planned: Undecided
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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.
Marco Cecchi, PhD principal investigator
COGNISION
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 Healthy, run by Neuronetrix, Inc. 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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 29 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vickie Tang ((502) 294-5109, vtang@cognision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude for parameters from the Active, Auditory Oddball ERP test. (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05869032, which also lists 5 linked publications.
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 29 Mar 2024.