Objective Brain Function Assessment of mTBI/Concussion

Brain Injuries, Traumatic Clinical Trial

— CAS13-25  

Official title:

Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation in Concussion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963804
• Other study ID #: 31-Ahead
• Status: Completed
• Start date: June 11, 2018
• Est. completion date: March 29, 2019

Study information

• Verified date: May 2019
• Source: BrainScope Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: March 29, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Brain
• Concussion, Intermediate
• Concussion, Mild
• Concussion, Severe

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.

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan
United States	University of Arkansas	Fayetteville	Arkansas
United States	University of Miami	Miami	Florida
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
BrainScope Company, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Derivation of algorithm for Likelihood of being concussed using multimodal inputs	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)	6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP