Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes

Completed

Conditions studied: Normative, Concussed

In brief

This study's objectives are: * To prospectively examine changes in brain network activation (BNA™) from baseline to recovery (i.e., return to activity) in youth and adolescent athletes with concussion. * To assess the clinical utility of changes in BNA to assist in clinical decision-making. * To generate normative BNA data.

Key facts

Study ID

NCT02105935

Run by

ElMindA Ltd

People needed

200

Starts

2014-04-01

Expected to finish

2018-06-01

Last updated by the study team

2020-07-22

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• • Male and Female Athletes: Age 8-14 (Arm 1) or 8-18 years (Arm 2).
• For Arm 1 - Over 3 days and below 7 days post-concussion (sports-related) and currently symptomatic
• 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 Parental consent

You may not qualify if…

• Currently with lice or open wounds on scalp.
• Long and thick hair that prevents the proper administration of an EEG cap.
• Significant sensory deficits, e.g., deafness or blindness.
• Normative Exclusion Criteria:
• Any chronic disease as determined by clinical evaluation and medical history.
• 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.
• Substance abuse in the last 3 months.
• History of any clinically significant brain trauma as determined by the investigator.

Where it is running

• Cincinnati children's hospital Sport center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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