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Validation of Brain Function Assessment Algorithm for mTBI From Initial Injury to Rehabilitation (CAS 13-25)

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ClinicalTrials.gov Identifier: NCT03671083
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
BrainScope Company, Inc.

Brief Summary:
This study is a validation of prior algorithms applied to the 13-25 year old population.

Condition or disease Intervention/treatment
Brain Injuries, Traumatic Concussion, Mild Concussion, Severe Concussion, Intermediate Device: BrainScope Ahead300iP Evaluation

Detailed Description:

EEG and clinical data will be collected to develop algorithms for the age group 13-25 years which will enable the sponsor to refine and validate existing algorithms for the adult populations. Subjects will come from the sports and other populations of concussed individuals. They will be matched with controls who will also undergo the same set of tests.

This study will develop an algorithm which will then help to validate/refine the existing algorithm (18-85 years of age) to apply to the 13-25 year old population.


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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validation of Brain Function Assessment Algorthm for mtBI From Initial Injury to Rehabilitation and Treatment Optimization in Concussion Clinics
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort Intervention/treatment
Matched Controls
Matched Controls will be uninjured subjects who are recruited from community locations.
Device: BrainScope Ahead300iP Evaluation
The BrainScope Ahead300iP evaluation will consist of 5 tests to assess concussion: History and Physical; Mental Status and Cognitive Assessment; Electrophysiological Function; Neurocognitive Assessment,Ocular Motor Assessment.

Injured Subjects
Injured Subjects will be patients meeting exclusion/inclusion criteria presenting within 72 hours (3 days) of closed head injury.
Device: BrainScope Ahead300iP Evaluation
The BrainScope Ahead300iP evaluation will consist of 5 tests to assess concussion: History and Physical; Mental Status and Cognitive Assessment; Electrophysiological Function; Neurocognitive Assessment,Ocular Motor Assessment.




Primary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: 8 months ]
    Sensitivity and specificity of the identification of the likelihood of mTBI at the time of injury, compared to the standard of care diagnosis of concussion



Information from the National Library of Medicine

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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
Injured subjects will be recruited from concussion clinics and emergency rooms. Matched Controls will be recruited from community sites (such as preventative care clinics).
Criteria

Inclusion Criteria:

• Age ≥13 and <25 years old;

For Injured subjects:

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

For Matched Controls:

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

Exclusion Criteria:

  • Previously enrolled in the BrainScope CAS Studies;
  • 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);
  • Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection;
  • History of brain surgery or neurological disease;
  • Pregnant women;
  • 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);
  • Acute intoxication;
  • Evidence of illicit drug usage;

For Injured subjects:

  • Loss of consciousness ≥ 20 minutes related to the concussion injury;
  • Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope assessment;
  • 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671083


Contacts
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Contact: Doug Oberly 2407527689 ext 1015 doug.oberly@brainscope.com
Contact: Leslie Prichep, PhD 2407527680 ext 1030 leslie.prichep@brainscope.com

Locations
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United States, Arkansas
University of Arkansas Not yet recruiting
Fayetteville, Arkansas, United States, 72701
Contact: Robert J Elbin, PhD    479-575-5262    rjelbin@uark.edu   
United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Gillian Hotz, PhD    305-243-2074    GHotz@miami.med.edu   
United States, Michigan
Michigan State University Not yet recruiting
East Lansing, Michigan, United States, 48824
Contact: Tracy Covassin, PhD    517-353-2100    covassin@msu.edu   
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Kian Merchant-Borna, MPH, MBA    585-275-2909    Kian_Merchant-Borna@URMC.Rochester.edu   
Sponsors and Collaborators
BrainScope Company, Inc.
Investigators
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Principal Investigator: Leslie Prichep, PhD BrainScope Inc.

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Responsible Party: BrainScope Company, Inc.
ClinicalTrials.gov Identifier: NCT03671083     History of Changes
Other Study ID Numbers: 52-Ahead
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by BrainScope Company, Inc.:
Concussion
Sports related concussion
Mild Traumatic Brain Injury

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases