Recruiting

Observational Study

Sponsor:

Neuronetrix, Inc.

Code:

NCT05869032

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 20 - 59

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT05869032

Start date

May 22, 2023

Status verified date

Mar, 2024

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Jul 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 59

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Amplitude for parameters from the Active, Auditory Oddball ERP test. [ Time Frame: Day 1 ]
  • Latency for parameters from the Active, Auditory Oddball ERP test. [ Time Frame: Day 1 ]
  • Task accuracy from the behavioral response during the Active, Auditory Oddball ERP test. [ Time Frame: Day 1 ]
  • Reaction Time from the behavioral response during the Active, Auditory Oddball ERP test. [ Time Frame: Day 1 ]
  • QEEG measures from the Vigilance EEG [ Time Frame: Day 1 ]
  • QEEG measures from the Eyes-closed Resting EEG [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Locations

Cognision

Recruiting

Louisville, Kentucky, United States, 40214

Contacts

Principal Investigator:

Marco Cecchi, PhD

More Information

Sponsor

Neuronetrix, Inc.

Last update posted

Mar 29, 2024

Last verified

Mar, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neuronetrix, Inc. on 2024-03-29.