Unblinded Data Collection Study of Concussion Using BrainPulse
18 settembre 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
353
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Wyoming
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Laramie, Wyoming, Stati Uniti, 82070
- University of Wyoming
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 28 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Athletes participating in Division 1 Athletics at the University of Wyoming
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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.
|
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.
|
|
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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Comparison of BrainPulse recordings of concussed subjects with BrainPulse recordings from their matched Controls
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Correlate helmet sensor's force of impact measurements with BrainPulse data
Lasso di tempo: Through study completion, expected to be 8 months
|
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.
|
Through study completion, expected to be 8 months
|
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Compare BrainPulse Data between Injured Athletes, Non-Injured athletes, and Concussed Athletes
Lasso di tempo: Through study completion, expected 8 months
|
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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 novembre 2016
Completamento primario (Effettivo)
1 maggio 2017
Completamento dello studio (Effettivo)
1 agosto 2017
Date di iscrizione allo studio
Primo inviato
12 dicembre 2016
Primo inviato che soddisfa i criteri di controllo qualità
12 dicembre 2016
Primo Inserito (Stima)
14 dicembre 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 settembre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 settembre 2018
Ultimo verificato
1 settembre 2018
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- JMC-1602
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
All study outcome measures will be made available within 6 months of study completion
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .