Healthy Controls Clinical Trial
Official title:
Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents and Young Adults
NCT number | NCT01460394 |
Other study ID # | ELM-02 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2011 |
Est. completion date | April 2012 |
Verified date | October 2019 |
Source | ElMindA Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in two age groups: adolescents and young adults.
Status | Completed |
Enrollment | 64 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 24 Years |
Eligibility |
Inclusion Criteria: - Age 15-24 years. - Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self). Exclusion Criteria: - Currently participate in a contact sport (e.g., football, hockey, soccer, rugby, lacrosse, martial arts). - Currently with lice, open wounds on scalp. - Any chronic disease. - Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. - Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. - Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc. - 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. - Substance abuse in the last 3 months. - Significant sensory deficits, e.g., deafness or blindness. - History of any brain trauma. |
Country | Name | City | State |
---|---|---|---|
United States | Vince and Associates Clinical Research | Overland Park | Kansas |
Lead Sponsor | Collaborator |
---|---|
ElMindA Ltd |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data | The study outcome measure are functional networks of brain activity of healthy adolescents (age 15-18 years) and young adults (19-24 years) established based on an analysis of EEG data recorded while study subjects perform ERP tasks | 1 week |
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