Normative QEEG/ERP Data for Healthy Volunteers

Launched by NEURONETRIX, INC. · May 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how brain activity works in healthy adults aged 20 to 59. Researchers want to gather data using a special system called COGNISION® that measures brain signals. These measurements will help create a baseline or reference for comparing brain function in people with neurological and psychiatric disorders. This study will complement previous research that focused on older adults.

To participate, you need to be a healthy male or female between 20 and 59 years old and be able to give a picture ID. You should be comfortable wearing a cap with electrodes for the testing, which will measure your brain activity. It's important that you haven't participated in another clinical study in the last month and that you don’t have a history of certain health issues, like Alzheimer’s, depression, or brain injuries. If you qualify, you'll be contributing valuable information that could help in understanding brain health better!

Gender

ALL

Eligibility 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.