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出境医 / 临床实验 / Objective Brain Function Assessment of mTBI/Concussion (CAS13-25)

Objective Brain Function Assessment of mTBI/Concussion (CAS13-25)

Study Description
Brief Summary:
This study (Part 3) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery.

Condition or disease Intervention/treatment
Brain Injuries, Traumatic Concussion, Mild Concussion, Intermediate Concussion, Severe Concussion, Brain Device: BrainScope Ahead 300iP

Detailed Description:
Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Subjects will come from the sports and other populations of concussed individuals. They will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. An additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.
Study Design
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Study Type : Observational
Actual Enrollment : 268 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation in Concussion
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : January 25, 2019
Actual Study Completion Date : March 29, 2019
Arms and Interventions
Group/Cohort Intervention/treatment
Injured and Matched Control Subject Pool
Injured subjects consist of subjects who are head injured and meet the inclusion/exclusion criteria. Injured subjects will be tested within 72 hours (3 days) of injury and at specified time points post injury. Matched control subjects will be tested at the same time intervals as the injured subject. BrainScope Battery will be performed at each time point and consists of the following components: brain electrical activity (EEG), neurocognitive performance assessment, ocular motor assessment, and clinical symptoms/assessments.
 Device: BrainScope Ahead 300iP
The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.
Healthy Volunteer Subject Pool
This subject pool will consist of uninjured (not head injured) subjects and will be tested at a single time point. These subjects will perform the same BrainScope Battery as the injured and matched control subjects.
 Device: BrainScope Ahead 300iP
The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.
Outcome Measures
Primary Outcome Measures :
  1. Derivation of algorithm for Likelihood of being concussed using multimodal inputs [ Time Frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP ]
    Create a database of all assessments including brain electrical activity (EEG features including all frequency bands and measures (power, connectivity,complexity), neurocognitive performance tests scores (throughput measures), balance, and clinical/symptom assessments (SCAT5), to support derivation of a multimodal brain function/concussion index. (NOTE: All EEG and Neurocognitive features are expressed as z-scores relative to age expected normal values to enable combination)


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Approximately 490 Injured, Matched Control and Healthy Volunteer subjects will be recruited from high schools, college universities, concussion clinics and emergency rooms.
Criteria

Inclusion Criteria:

For Injured subjects:

  1. Having sustained a traumatic closed head injury within 72 hours (3 days) from time of injury at time of BrainScope assessment;
  2. GCS 13-15 at time of BrainScope assessment;
  3. No hospital admission due to either head injury or collateral injuries for >24 hours.

For Matched Controls:

  1. GCS 15 at time of BrainScope assessment;
  2. No prior history of concussion or TBI in the last year.

Exclusion Criteria:

  1. Previously enrolled in the BrainScope CAS Studies;
  2. Current CNS active prescription medications taken daily, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD);
  3. Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection;
  4. History of brain surgery or neurological disease;
  5. Pregnant women;
  6. Subjects who do not speak English (non-English speaking parents are allowed to consent so long as translation of the consent form in their native language is available);
  7. Acute intoxication;
  8. Evidence of illicit drug usage;

For Injured subjects:

  1. Loss of consciousness ≥ 20 minutes related to the concussion injury;
  2. Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope assessment;
  3. Evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment).

For Matched Controls:

  1. Any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech;
  2. History of Motor Vehicle Accident (MVA) requiring an Emergency Department visit within the past 1 year.
Contacts and Locations

Locations
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United States, Arkansas
University of Arkansas
Fayetteville, Arkansas, United States, 72701
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
BrainScope Company, Inc.
Investigators
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Study Director: Leslie Prichep, Ph.D. BrainScope Company, Inc.
Tracking Information
First Submitted Date May 21, 2019
First Posted Date May 28, 2019
Last Update Posted Date May 28, 2019
Actual Study Start Date June 11, 2018
Actual Primary Completion Date January 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 22, 2019) 		Derivation of algorithm for Likelihood of being concussed using multimodal inputs [ Time Frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP ]
Create a database of all assessments including brain electrical activity (EEG features including all frequency bands and measures (power, connectivity,complexity), neurocognitive performance tests scores (throughput measures), balance, and clinical/symptom assessments (SCAT5), to support derivation of a multimodal brain function/concussion index. (NOTE: All EEG and Neurocognitive features are expressed as z-scores relative to age expected normal values to enable combination)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
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 Objective Brain Function Assessment of mTBI/Concussion
Official Title Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation in Concussion
Brief Summary This study (Part 3) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery.
Detailed Description Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Subjects will come from the sports and other populations of concussed individuals. They will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. An additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.
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 Approximately 490 Injured, Matched Control and Healthy Volunteer subjects will be recruited from high schools, college universities, concussion clinics and emergency rooms.
Condition
  • Brain Injuries, Traumatic
  • Concussion, Mild
  • Concussion, Intermediate
  • Concussion, Severe
  • Concussion, Brain
Intervention Device: BrainScope Ahead 300iP
The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.
Study Groups/Cohorts
  • Injured and Matched Control Subject Pool
    Injured subjects consist of subjects who are head injured and meet the inclusion/exclusion criteria. Injured subjects will be tested within 72 hours (3 days) of injury and at specified time points post injury. Matched control subjects will be tested at the same time intervals as the injured subject. BrainScope Battery will be performed at each time point and consists of the following components: brain electrical activity (EEG), neurocognitive performance assessment, ocular motor assessment, and clinical symptoms/assessments.
    Intervention: Device: BrainScope Ahead 300iP
  • Healthy Volunteer Subject Pool
    This subject pool will consist of uninjured (not head injured) subjects and will be tested at a single time point. These subjects will perform the same BrainScope Battery as the injured and matched control subjects.
    Intervention: Device: BrainScope Ahead 300iP
Publications * Covassin T, McGowan AL, Bretzin AC, Anderson M, Petit KM, Savage JL, Katie SL, Elbin RJ, Pontifex MB. Preliminary investigation of a multimodal enhanced brain function index among high school and collegiate concussed male and female athletes. Phys Sportsmed. 2020 Nov;48(4):442-449. doi: 10.1080/00913847.2020.1745717. Epub 2020 Mar 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 22, 2019) 		268
Original Actual Enrollment Same as current
Actual Study Completion Date March 29, 2019
Actual Primary Completion Date January 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

For Injured subjects:

  1. Having sustained a traumatic closed head injury within 72 hours (3 days) from time of injury at time of BrainScope assessment;
  2. GCS 13-15 at time of BrainScope assessment;
  3. No hospital admission due to either head injury or collateral injuries for >24 hours.

For Matched Controls:

  1. GCS 15 at time of BrainScope assessment;
  2. No prior history of concussion or TBI in the last year.

Exclusion Criteria:

  1. Previously enrolled in the BrainScope CAS Studies;
  2. Current CNS active prescription medications taken daily, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD);
  3. Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection;
  4. History of brain surgery or neurological disease;
  5. Pregnant women;
  6. Subjects who do not speak English (non-English speaking parents are allowed to consent so long as translation of the consent form in their native language is available);
  7. Acute intoxication;
  8. Evidence of illicit drug usage;

For Injured subjects:

  1. Loss of consciousness ≥ 20 minutes related to the concussion injury;
  2. Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope assessment;
  3. Evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment).

For Matched Controls:

  1. Any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech;
  2. History of Motor Vehicle Accident (MVA) requiring an Emergency Department visit within the past 1 year.
Sex/Gender
Sexes Eligible for Study: All
Ages 13 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03963804
Other Study ID Numbers 31-Ahead
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement Not Provided
Responsible Party BrainScope Company, Inc.
Study Sponsor BrainScope Company, Inc.
Collaborators Not Provided
Investigators
Study Director: Leslie Prichep, Ph.D. BrainScope Company, Inc.
PRS Account BrainScope Company, Inc.
Verification Date May 2019

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