Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT05869032
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
59 Years
Study:
NCT05869032
Study Brief:
Protocol Section:
NCT05869032