RECRUITING

Normative QEEG/ERP Data for Healthy Volunteers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-05-22
Study Completion:2024-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05869032

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.

Ages Eligible for Study:20 Years to 59 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male and female volunteers 20-59 years of age, inclusive.
  2. 2. Willingness and ability to provide 1 form of identification with picture.
  3. 3. Willingness and ability to provide to understand the requirements of the study, provide written informed consent, and abide by the study procedures.
  4. 4. Fluency in English, even if English is not the primary language.
  5. 5. Ability to tolerate the electrode cap for the duration of the testing session.
  6. 6. Subject has not been enrolled or actively participating in another clinical study 4 weeks prior to testing.
  1. 1. History of neurological and/or psychiatric disorders:
  2. * Diseases of the Dementia type (i.e. Alzheimer's Disease, Vascular Dementia, Parkinson's Disease Dementia etc.)
  3. * Epileptic seizures
  4. * Bipolar Disorder
  5. * Autism Spectrum Disorder
  6. * Depression
  7. * Brain tumor(s)
  8. * Multiple Sclerosis
  9. * Schizophrenia or Schizoaffective Disorder
  10. * Stroke (ischemic or hemorrhagic)
  11. * Traumatic Brain Injury
  12. * Current Drug or Alcohol Abuse
  13. 2. Diagnosis with HIV/AIDS
  14. 3. Inability to detect a 1000Hz tone at 40dB in either ear.
  15. 4. Recent (24 hours) use of medications known to affect QEEG/ERP (cannabinoids, sleep aides, benzodiazepines, opiates/opioids, amphetamines, or barbiturates).
  16. 5. Recent (day of study) use of energy drinks, including pre-workout drinks and over the counter energy supplements and nootropics.
  17. 6. Caffeine, alcohol, or products containing nicotine within 1 hour of testing.
  18. 7. Known allergy to latex.
  19. 8. Any impairment, activity, or situation that, in the judgment of the study Sponsor, would prevent satisfactory completion of the study protocol.

Contacts and Locations

Study Contact

Vickie Tang
CONTACT
(502) 294-5109
vtang@cognision.com

Principal Investigator

Marco Cecchi, PhD
PRINCIPAL_INVESTIGATOR
COGNISION

Study Locations (Sites)

Cognision
Louisville, Kentucky, 40214
United States

Collaborators and Investigators

Sponsor: Neuronetrix, Inc.

  • Marco Cecchi, PhD, PRINCIPAL_INVESTIGATOR, COGNISION

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 Registration Dates

Study Start Date2023-05-22
Study Completion Date2024-09-30

Study Record Updates

Study Start Date2023-05-22
Study Completion Date2024-09-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Healthy