NCT02418208

Normative Data Base of Brain Network Activation (BNA) Using Evoked Response Potentials

Clinical Trial Protocol for the Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents, Young Adults and Adults

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 964 (actual)
• Sponsor: ElMindA Ltd · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Normative

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Performint EEG tests and BNA analysis

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-08-01
• Completion: 2019-11-01
• First posted: 2015-04-16
• Last updated: 2019-11-26

Locations

5 sites across 2 countries: United States, India