Collecting brain function data from healthy adults
Establishing Normative Values for Event Related Potentials (ERPs) and Quantitative EEG (QEEG) in Adult, Healthy Volunteers
This study is trying to collect brain function data from healthy adults aged 20 to 59 to help understand how their brains work compared to those with neurological and psychiatric conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 59 Years |
| Sex | All |
| Sponsor | Neuronetrix, Inc. Industry-sponsored |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT05869032 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather normative data on brain function using advanced EEG techniques from healthy adults aged 20 to 59. Participants will undergo a series of tests, including event-related potentials (ERP) and quantitative electroencephalography (QEEG), to establish reference values that can be compared against individuals with neurological and psychiatric disorders. The study will complement existing data from older healthy subjects, enhancing the understanding of brain function across different age groups. All assessments will be conducted in a single visit lasting up to 90 minutes.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 20 to 59 who can provide informed consent and tolerate the testing procedures.
Not a fit: Patients with a history of neurological or psychiatric disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable reference data to improve the diagnosis and treatment of neurological and psychiatric disorders.
How similar studies have performed: Previous studies have successfully utilized similar approaches to establish normative data for brain function, indicating a promising avenue for this research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Louisville, Kentucky
- Cognision — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Marco Cecchi, PhD — Cognision
- Study coordinator: Vickie Tang
- Email: vtang@cognision.com
- Phone: (502) 294-5109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.