Normative Data Base of Brain Network Activation (BNA) Using Evoked Response Potentials
- Conditions
- Normative
- Interventions
- Diagnostic Test: Performint EEG tests and BNA analysis
- Registration Number
- NCT02418208
- Lead Sponsor
- ElMindA Ltd
- Brief Summary
Purpose: EEstablish normative data of ElMindA's Brain Network Activation (BNA) using evoked response potentials in adolescents, young adults and Adults.
Trial design: Open, one-arm, prospective, age-stratified, multi site. Enrollment size: Up to 1500 subjects will be enrolled in 4 or more sites. Study duration: Each patient will be followed up for up to 1 year. Overall study duration will be up to 1.5 years. Patient population: Adolescents, young adults and Adults of both genders.
Age range:
* 10-11.99
* 12-13.99
* 14-15.99
* 16-17.99
* 18-24.99
* 25-29.99
* 30-34.99
* 35-39.99
* 40-44.99
* 45-49.99
* 50-54.99
* 55-60
* 60 and above
Objective: Establishment of normative data of BNA.
- Detailed Description
Currently, there is no reliable, bedside, and non-invasive method for assessing connectivity 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 non-invasive 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 964
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Test retest- 2 visits Performint EEG tests and BNA analysis Eligible participants will arrive for 2 testing visits a week apart and an optional third visit within 6-12 months. Single Visit Performint EEG tests and BNA analysis Eligible participants will arrive for a single testing visit
- Primary Outcome Measures
Name Time Method Developing a BNA database for normative population. 1.5 years Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Psychiatric Medicine Associates, Llc
🇺🇸Skokie, Illinois, United States
Ohio Clinical Trials, Inc.
🇺🇸Columbus, Ohio, United States
Clinical trials of the Rockies, Inc.
🇺🇸Denver, Colorado, United States
Cytespace Research Private Limited
🇮🇳Banglore, India