Normative QEEG/ERP Data for Healthy Volunteers

NCT05869032 | Recruiting

• 1 other identifier: SRP-1951
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Brain Function; Normative Values; Event-Related Potentials (ERP); Quantitative Electroencephalography (QEEG); Cognitive Processing; Frequency; Amplitude; Brain Activity; Electroencephalogram; Neural Processing

Outcome Measures

Primary Outcomes (6)

• Amplitude for parameters from the Active, Auditory Oddball ERP test.

  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.

  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.

  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.

  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

  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

  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

Study Arms (8)

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

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Neuronetrix, Inc.: lead

Study Sites (1)

Cognision

Louisville, Kentucky, 40214, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 36921403 RESULT

• Cecchi 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.

  PMID: 27239520 RESULT

• Haller, 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

  RESULT

• 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.

  PMID: 23075830 RESULT

• van 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.

  PMID: 24551055 RESULT

Study Officials

• Marco Cecchi, PhD

  COGNISION

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vickie Tang

CONTACT

(502) 294-5109; vtang@cognision.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: May 22, 2023
• Primary Completion: July 31, 2024
• Study Completion: September 30, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

US (1)