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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

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ClinicalTrials.gov Identifier: NCT02105935
Recruitment Status : Recruiting
First Posted : April 7, 2014
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
ElMindA Ltd

Tracking Information
First Submitted Date April 3, 2014
First Posted Date April 7, 2014
Last Update Posted Date May 29, 2019
Study Start Date April 2014
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2014)
quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test. [ Time Frame: 1 year ]
quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02105935 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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.
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population male and female athletes
Condition
  • Normative
  • Concussed
Intervention Not Provided
Study Groups/Cohorts
  • Normative study
    male and female athletes, ages 8-14.
  • Baseline
    male and female athletes, ages 8-18.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 4, 2014)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Kim Foss, MS 513-636-5971 kim.foss@cchmc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02105935
Other Study ID Numbers ELM-23
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ElMindA Ltd
Study Sponsor ElMindA Ltd
Collaborators Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Gregory Myer, PhD Children's Hospital Medical Center, Cincinnati
PRS Account ElMindA Ltd
Verification Date September 2018