Trial record 1 of 3 for:    ELM-23
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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by ElMindA Ltd
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
ElMindA Ltd
ClinicalTrials.gov Identifier:
NCT02105935
First received: April 3, 2014
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.

Condition
Normative
Concussed

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Further study details as provided by ElMindA Ltd:

Primary Outcome Measures:
  • quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.


Estimated Enrollment: 200
Study Start Date: April 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normative study
male and female athletes, ages 8-14.
Baseline
male and female athletes, ages 8-18.

Detailed Description:

Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA™) to temporally and spatially map brain function, connectivity and synchronization.

The proposed study will provide additional evidence for the utility and contribution of the BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion) in concussion management.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

male and female athletes

Criteria

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105935

Contacts
Contact: Kim Foss, MS 513-636-5971 kim.foss@cchmc.org

Locations
United States, Ohio
Cincinnati children's hospital Sport center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Kim Foss, MS    513-636-5971    kim.foss@cchmc.org   
Principal Investigator: Gregory Myer, PHD         
Sponsors and Collaborators
ElMindA Ltd
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Gregory Myer, PhD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: ElMindA Ltd
ClinicalTrials.gov Identifier: NCT02105935     History of Changes
Other Study ID Numbers: ELM-23
Study First Received: April 3, 2014
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 22, 2014