Unblinded Data Collection Study of Concussion Using BrainPulse
18 września 2018 zaktualizowane przez: Jan Medical, Inc.
A Study to Assess the Effectiveness of the BrainPulse as an Aid to the Diagnosis of Concussion
This is a prospective, non-blinded, matched control study of young athletes (ages 10-28 years old) in collegiate sports.
The cohorts are defined in accordance to the athlete's exposure of injury.
All subjects will complete a minimum of one recording based on their assigned cohort.
Concussed athletes will complete an additional 3 weeks of follow-up recordings post injury.
The symptomatic evaluation, physical examination, neurological baseline testing, and BrainPulse recordings will be entered in a database to determine clinical outcome and assess device utilization.
Przegląd badań
Szczegółowy opis
Cohort I is defined as all enrolled athletes at the University of Wyoming and is divided into two sub-cohorts: Cohort Ia include all athletes participating in Division 1 Athletics; Cohort Ib are athletes subscribed to the Head Health Network.
Cohort II is defined as all injured athletes participating in the teams and includes two sub-cohorts: Cohort IIa is defined as non- concussed injured athletes; Cohort IIb concussed athletes per reference standard.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
353
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Wyoming
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Laramie, Wyoming, Stany Zjednoczone, 82070
- University of Wyoming
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 28 lat (Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Athletes participating in Division 1 Athletics at the University of Wyoming
Opis
Inclusion Criteria:
- Male or female young athletes between ages 18-28 yrs
- Enrolled at the University of Wyoming and currently participating in Division 1 Athletics
- Completed the following baseline testing: SWAY balance, King-Devick, C3-Logix
- Willing and able to participate in all study evaluations and allow access to medical testing and records
- Signed informed consent, or have a legally authorized representative willing to provide informed consent on behalf of the subject if the subject is a minor
Exclusion Criteria:
- Prior concussion diagnosed by a physician in the last 2 weeks assessed via interview with athlete (not including a recent concussion within the last 3 days)
- Any serious medical, social or psychological condition that in the opinion of the investigator would impair ability to provide informed consent or otherwise disqualify a patient from participation
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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Cohort Ia
Athletes in this cohort serve as control subjects participating in Division 1 Athletics at the University of Wyoming.
They will be enrolled once they meet eligibility.
Upon enrollment, all athletes will have an initial BrainPulse recording.
Once a subject from this cohort sustains an injury, they crossover to Cohort II.
Also, a matched control for every concussed subject will be selected from Cohort Ia.
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JanMedical's BrainPulse measures the brain motion caused by pulsatile blood flow from the cardiac cycle referred to as the BrainPulse signal.
The BrainPulse measures skull acceleration in response to tge brain motion using an array of sensors placed on the head.
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Cohort Ib
Athletes in this cohort are subjects currently subscribed to the Head Health Network.
They will have a BrainPulse recording completed every week through the entire season.
Similarly, if subjects in this cohort sustain an injury, they will crossover to Cohort II.
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JanMedical's BrainPulse measures the brain motion caused by pulsatile blood flow from the cardiac cycle referred to as the BrainPulse signal.
The BrainPulse measures skull acceleration in response to tge brain motion using an array of sensors placed on the head.
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Cohort IIa
Athletes from Cohort I will be assigned to cohort IIa once they sustain an injury other than concussion.
They will have been pulled out of the game by the athletic trainer and removed from play until at least the end of the game.
Once the subjects have been assigned to Cohort IIa, they will have a BrainPulse recording and a symptom evaluation within 3 days of their injury.
After two weeks of recovery, subjects in this cohort will return to Cohort 1 and resume their participation in the study in their respective sub-cohort.
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JanMedical's BrainPulse measures the brain motion caused by pulsatile blood flow from the cardiac cycle referred to as the BrainPulse signal.
The BrainPulse measures skull acceleration in response to tge brain motion using an array of sensors placed on the head.
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Cohort IIb
Athletes in this cohort are injured subjects who sustain a non-penetrating head injury and are confirmed to have had a concussion according to the protocol reference standard and by their physician.
All subjects enrolled in this cohort are required to have a BrainPulse recording within 3 days of their injury.
Each BrainPulse recording will be accompanied by a symptoms evaluation and medical data collection documented in the case report forms.
Subjects will complete 3 weeks of follow-up visits post injury.
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JanMedical's BrainPulse measures the brain motion caused by pulsatile blood flow from the cardiac cycle referred to as the BrainPulse signal.
The BrainPulse measures skull acceleration in response to tge brain motion using an array of sensors placed on the head.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Comparison of BrainPulse recordings of concussed subjects with BrainPulse recordings from their matched Controls
Ramy czasowe: Through study completion, expected to be 8 months
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Collect BrainPulse data from at least 15 concussed athletes and matched controls to develop and improve algorithms that can aid in the diagnosis of concussion. The specific signal patterns observed from confirmed concussed subjects' BrainPulse recordings will be evaluated against the BrainPulse recordings from the matched control subjects. |
Through study completion, expected to be 8 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Correlate helmet sensor's force of impact measurements with BrainPulse data
Ramy czasowe: Through study completion, expected to be 8 months
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Compare the magnitude of force measured by helmet sensors from subconcussive hits with consecutive BrainPulse recordings.
As such, BrainPulse data on these athletes will be compared with helmet sensor data, baseline cognitive testing, and the initial BrainPulse recording.
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Through study completion, expected to be 8 months
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Compare BrainPulse Data between Injured Athletes, Non-Injured athletes, and Concussed Athletes
Ramy czasowe: Through study completion, expected 8 months
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Compare BrainPulse signals in subjects sustaining a non-concussive injury to subjects that have a confirmed diagnosis of concussion.
Also compare BrainPulse signals from injured subjects in Cohort IIa with non-injured subjects in Cohort Ia.
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Through study completion, expected 8 months
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 listopada 2016
Zakończenie podstawowe (Rzeczywisty)
1 maja 2017
Ukończenie studiów (Rzeczywisty)
1 sierpnia 2017
Daty rejestracji na studia
Pierwszy przesłany
12 grudnia 2016
Pierwszy przesłany, który spełnia kryteria kontroli jakości
12 grudnia 2016
Pierwszy wysłany (Oszacować)
14 grudnia 2016
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
20 września 2018
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
18 września 2018
Ostatnia weryfikacja
1 września 2018
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- JMC-1602
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
All study outcome measures will be made available within 6 months of study completion
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .