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

Completed

Conditions studied: Normative

In brief

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.

Key facts

Study ID

NCT02418208

Run by

ElMindA Ltd

People needed

964

Starts

2015-03-01

Expected to finish

2019-11-01

Last updated by the study team

2019-11-26

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Clinical trials of the Rockies, Inc. — Denver, Colorado, United States
• Psychiatric Medicine Associates, Llc — Skokie, Illinois, United States
• Clinical Research Center of Nevada — Las Vegas, Nevada, United States
• Ohio Clinical Trials, Inc. — Columbus, Ohio, United States
• Cytespace Research Private Limited — Banglore, India

Full record on ClinicalTrials.gov

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