To establish a database based on healthy individuals by using an EEG to capture electronic recordings in adolescents, young adults and adults.
- Registration Number
- CTRI/2017/02/007862
- Lead Sponsor
- ElMindA LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 1500
1. Age 10-years and above.
2. Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
3. Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).
1. Has participated in the past 6 months in an organized contact sport activity (e.g., football, hockey, soccer, rugby, lacrosse, martial arts, Boxing).
2. Currently with lice or open wounds on scalp.
3. Any chronic disease or condition which affects the nervous system as determined by clinical neurological evaluation, medical history and PI discretion.
4. Active (within 1 month) Migraine history or clinically significant reoccurring Migraine episodes.
5. Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)
6. Any CNS neurologic or neuropsychological disorders, as determined by clinical evaluation
8. History of Special education,
9. History of any medication affecting CNS within the last 3 months,
10. Substance abuse in the last 3 months and any clinically significant substance dependency as determined by the MINI evaluation and PI discretion.
11. Significant sensory deficits, e.g., deafness or blindness.
12. Pregnant women or women that are 1 month following a childbirth.
13. History of any clinically significant brain trauma as determined by the investigator.
14. History of more than 1 clinically diagnosed concussion.
15. Clinically diagnosed with a concussion in the past year.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective of this study is to establish the normative data for adolescents, young adults and Adults.Timepoint: Day 0, 7, 180 & 365
- Secondary Outcome Measures
Name Time Method Hypothesis-generating study designed to collect data that will aid in future scientific and engineering explorationTimepoint: Day 0, 7, 180 & 365