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An Investigator Initiated Study to Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion

8. april 2015 oppdatert av: ElMindA Ltd

Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth Athletes

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.

The BNA test is basically divided to 3 phases - first EEG data is collected from subjects using an EEG system while the subject is performing a cognitive task in front of a computer. The EEG data is then analyzed using the advanced BNA™ technology. Finally, a report of the BNA™ test is generated.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

A single center study evaluating the effectiveness of BNA technology as an objective tool for sport related concussion management in youth athletes' populations.

The study will include 150 athletes from Minnesota Youth Hockey Programs. Subjects enrolled in this study will undergo a screening and baseline pre season visit and follow up visit/s.

  1. Follow-up testing for concussed athletes - Concussed athletes will complete a series of post concussion follow up visits. Each will consist of BNA™ test, ImPACT™ test, and exam by neurologist or neurology nurse practitioner. The first visit will be within 72 hours of injury and re-evaluations will occur weekly until BNA has normalized AND subject is asymptomatic. Subject may return to play at that point and subject will have a final additional BNA™ test one week after the athlete returns to full activity. If participant is still symptomatic and/or BNA is still abnormal at 6 weeks reevaluations go to every 2 weeks for up to three months or clearing of symptoms AND normal BNA™. If not back to baseline at three months, monthly reevaluations until study completion.
  2. Follow up visit for non-concussed athletes - non-concussed athletes will complete a follow up visit upon completion of the sport season.

Studietype

Observasjonsmessig

Registrering (Faktiske)

145

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55407
        • Noran Neurological Clinic

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

11 år til 15 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

150 male athletes enrolled in Minnesota Youth Hockey Programs, aged 11-15 years.

Beskrivelse

Inclusion Criteria:

  • Male athletes
  • aged 11-15
  • enrolled in selected Minnesota Youth Hockey Programs

Exclusion Criteria:

  • Self-reported history of central nervous system injury or disease (examples will include, but will not be limited to, moderate or severe traumatic brain injury (TBI with a Glasgow Coma Scale < 13), epilepsy, seizures, brain surgery, or any positive neuroimaging results)
  • Active head lice infection, open scalp wound
  • Deafness, and/or blindness
  • A concussion within prior six months
  • Residual symptoms or deficits related to a previous concussion
  • Long and thick hair that prevents the proper administration of an EEG cap.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Healthy Athletes
Concussed Athletes

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
changes in BNA™ measures during the sport season
Tidsramme: 1 year
Consistency or changes in BNA™ measures during and after the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.
1 year
Correlation of the BNA measures during the sport season in concussed athletes to the clinical diagnosis, symptom scores and the ImPACT test results.
Tidsramme: 1 year
Correlation of the BNA measures during the sport season in concussed athletes to the clinical diagnosis, symptom scores and the ImPACT test results.
1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

ElMindA Ltd

Samarbeidspartnere

Noran Neurological Clinic

Etterforskere

  • Hovedetterforsker: Steven s Lebow, MD, Noran Neurological Clinic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2013

Primær fullføring (Faktiske)

1. august 2014

Studiet fullført (Faktiske)

1. desember 2014

Datoer for studieregistrering

Først innsendt

10. oktober 2013

Først innsendt som oppfylte QC-kriteriene

13. oktober 2013

Først lagt ut (Anslag)

16. oktober 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. april 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. april 2015

Sist bekreftet

1. april 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ELM-22

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Sponsorer og samarbeidspartnere

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Forhold

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