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

NCT02105935 | Completed

• 1 other identifier: ELM-23
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Normative; Concussed

Outcome Measures

Primary Outcomes (1)

• quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.

  quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.

  1 year

Study Arms (2)

Normative study

male and female athletes, ages 8-14.

Baseline

male and female athletes, ages 8-18.

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

male and female athletes

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.
• 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.

Sponsors & Collaborators

• ElMindA Ltd: lead
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (1)

Cincinnati children's hospital Sport center

Cincinnati, Ohio, 45229-3039, United States

Location

Study Officials

• Gregory Myer, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 7, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

US (1)