- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01460394
Normative Data of Brain Network Activation in Adolescents and Young Adults
Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents and Young Adults
Study Overview
Status
Conditions
Detailed Description
Currently, there is no reliable, practical, and non-invasive method for assessing changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA) to temporally and spatially map brain function, connectivity and synchronization.
The need of objective measures that will help the clinician in its decision making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kansas
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Overland Park, Kansas, United States, 66212
- Vince and Associates Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 15-24 years.
- Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).
Exclusion Criteria:
- Currently participate in a contact sport (e.g., football, hockey, soccer, rugby, lacrosse, martial arts).
- Currently with lice, open wounds on scalp.
- Any chronic disease.
- Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc.
- Any CNS neurologic disorder, e.g., epilepsy, seizures, etc.
- Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc.
- History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.
- History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.
- Substance abuse in the last 3 months.
- Significant sensory deficits, e.g., deafness or blindness.
- History of any brain trauma.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy adolescents and young adults
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
Time Frame: 1 week
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The study outcome measure are functional networks of brain activity of healthy adolescents (age 15-18 years) and young adults (19-24 years) established based on an analysis of EEG data recorded while study subjects perform ERP tasks
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1 week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bradley D. Vince, D.O., Vince and Associates Clinical Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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