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

NCT02418208 | Completed

• 1 other identifier: ELM-25
• Study Type: observational
• Target: 964
• Locations: 2 countries
• Sites: 5

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.

Conditions

Normative

Outcome Measures

Primary Outcomes (1)

• Developing a BNA database for normative population.

  Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data

  1.5 years

Study Arms (2)

Test retest- 2 visits

Eligible participants will arrive for 2 testing visits a week apart and an optional third visit within 6-12 months.

Diagnostic Test: Performint EEG tests and BNA analysis

Single Visit

Eligible participants will arrive for a single testing visit

Diagnostic Test: Performint EEG tests and BNA analysis

Interventions

Performint EEG tests and BNA analysis DIAGNOSTIC_TEST

Single Visit; Test retest- 2 visits

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 1500 subjects, from both genders, aged 10 years and above will be recruited, stratified to age groups.

You may qualify if:

• Age 10-years and above.
• Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
• Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).

You may not qualify if:

• Has participated in the past 6 months in an organized contact sport activity (e.g., football, hockey, soccer, rugby, lacrosse, martial arts, Boxing).
• Currently with lice or open wounds on scalp.
• Any chronic disease or condition which affects the nervous system as determined by clinical neurological evaluation, medical history or PI discretion.
• Active (within 1 month) Migraine history or clinically significant reoccurring Migraine episodes.
• Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)
• Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical evaluation
• Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc. as determined by clinical evaluation
• 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. The investigator should consider including subjects which had used such drugs for a short period according to a logical calculation of the drug's half-life.
• Substance abuse in the last 3 months and any clinically significant substance dependency as determined by the MINI evaluation and PI discretion.
• Significant sensory deficits, e.g., deafness or blindness.
• Pregnant women or women that are 1 month following a childbirth.
• History of any clinically significant brain trauma as determined by the investigator.
• History of more than 1 clinically diagnosed concussion.
• Clinically diagnosed with a concussion in the past year. Minor deviations to eligibility criteria may be made on a case-by-case basis prior to enrollment if approved by the Sponsor, in writing, in agreement with the Investigator.

Sponsors & Collaborators

• ElMindA Ltd: lead

Study Sites (5)

Clinical trials of the Rockies, Inc.

Denver, Colorado, 80209, United States

Location

Psychiatric Medicine Associates, Llc

Skokie, Illinois, 60076, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

Ohio Clinical Trials, Inc.

Columbus, Ohio, 43212, United States

Location

Cytespace Research Private Limited

Banglore, 560092, India

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 16, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

IN (1); US (4)