<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02992795</url>
  </required_header>
  <id_info>
    <org_study_id>JMC-1602</org_study_id>
    <nct_id>NCT02992795</nct_id>
  </id_info>
  <brief_title>Unblinded Data Collection Study of Concussion Using BrainPulse</brief_title>
  <official_title>A Study to Assess the Effectiveness of the BrainPulse as an Aid to the Diagnosis of Concussion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jan Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jan Medical, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, non-blinded, matched control study of young athletes (ages 10-28 years&#xD;
      old) in collegiate sports. The cohorts are defined in accordance to the athlete's exposure of&#xD;
      injury. All subjects will complete a minimum of one recording based on their assigned cohort.&#xD;
      Concussed athletes will complete an additional 3 weeks of follow-up recordings post injury.&#xD;
      The symptomatic evaluation, physical examination, neurological baseline testing, and&#xD;
      BrainPulse recordings will be entered in a database to determine clinical outcome and assess&#xD;
      device utilization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cohort I is defined as all enrolled athletes at the University of Wyoming and is divided into&#xD;
      two sub-cohorts: Cohort Ia include all athletes participating in Division 1 Athletics; Cohort&#xD;
      Ib are athletes subscribed to the Head Health Network. Cohort II is defined as all injured&#xD;
      athletes participating in the teams and includes two sub-cohorts: Cohort IIa is defined as&#xD;
      non- concussed injured athletes; Cohort IIb concussed athletes per reference standard.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of BrainPulse recordings of concussed subjects with BrainPulse recordings from their matched Controls</measure>
    <time_frame>Through study completion, expected to be 8 months</time_frame>
    <description>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.&#xD;
The specific signal patterns observed from confirmed concussed subjects' BrainPulse recordings will be evaluated against the BrainPulse recordings from the matched control subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlate helmet sensor's force of impact measurements with BrainPulse data</measure>
    <time_frame>Through study completion, expected to be 8 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare BrainPulse Data between Injured Athletes, Non-Injured athletes, and Concussed Athletes</measure>
    <time_frame>Through study completion, expected 8 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">353</enrollment>
  <condition>Concussion, Intermediate</condition>
  <arm_group>
    <arm_group_label>Cohort Ia</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort Ib</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort IIa</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort IIb</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BrainPulse</intervention_name>
    <description>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.</description>
    <arm_group_label>Cohort IIa</arm_group_label>
    <arm_group_label>Cohort IIb</arm_group_label>
    <arm_group_label>Cohort Ia</arm_group_label>
    <arm_group_label>Cohort Ib</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Athletes participating in Division 1 Athletics at the University of Wyoming&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female young athletes between ages 18-28 yrs&#xD;
&#xD;
          2. Enrolled at the University of Wyoming and currently participating in Division 1&#xD;
             Athletics&#xD;
&#xD;
          3. Completed the following baseline testing: SWAY balance, King-Devick, C3-Logix&#xD;
&#xD;
          4. Willing and able to participate in all study evaluations and allow access to medical&#xD;
             testing and records&#xD;
&#xD;
          5. Signed informed consent, or have a legally authorized representative willing to&#xD;
             provide informed consent on behalf of the subject if the subject is a minor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior concussion diagnosed by a physician in the last 2 weeks assessed via interview&#xD;
             with athlete (not including a recent concussion within the last 3 days)&#xD;
&#xD;
          2. Any serious medical, social or psychological condition that in the opinion of the&#xD;
             investigator would impair ability to provide informed consent or otherwise disqualify&#xD;
             a patient from participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>28 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Wyoming</name>
      <address>
        <city>Laramie</city>
        <state>Wyoming</state>
        <zip>82070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>September 18, 2018</last_update_submitted>
  <last_update_submitted_qc>September 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Concussion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All study outcome measures will be made available within 6 months of study completion</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02992795
org study id: JMC-1602
nct id: NCT02992795
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Comparison of BrainPulse recordings of concussed subjects with BrainPulse recordings from their matched Controls
time frame: Through study completion, expected to be 8 months
description: 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.
measure: Correlate helmet sensor's force of impact measurements with BrainPulse data
time frame: Through study completion, expected to be 8 months
description: 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.
measure: Compare BrainPulse Data between Injured Athletes, Non-Injured athletes, and Concussed Athletes
time frame: Through study completion, expected 8 months
description: 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.
arm group label: Cohort Ia
description: 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.
arm group label: Cohort Ib
description: 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.
arm group label: Cohort IIa
description: 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.
arm group label: Cohort IIb
description: 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.
intervention type: Device
intervention name: BrainPulse
description: 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.
arm group label: Cohort IIa
arm group label: Cohort IIb
arm group label: Cohort Ia
arm group label: Cohort Ib
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 28 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Concussion
sharing ipd: No
ipd description: All study outcome measures will be made available within 6 months of study completion