Validation of Brain Function Assessment Algorithm for mTBI/Concussion

Brain Injuries, Traumatic Clinical Trial

— CAS13-25V  

Official title:

Validation of Brain Function Assessment Algorthm for mTBI From Initial Injury to Rehabilitation and Treatment Optimization in Concussion Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671083
• Other study ID #: 52-Ahead
• Status: Completed
• Start date: October 1, 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 is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms.

Description:

EEG, neurocognitive performance and clinical data will be collected at time of injury (within 3 days) at clinically determined Return to Play (RTP) and 45 days after RTP, for the purpose of independently validating the performance of the algorithms developed in prior studies (NCT02477943, NCT02661633 and NCTXXXXXX). Data collected under this study will be combined with that collected under NCT02957461 for the final analyses of prospective algorithm performance in an independent population ages 13-25 years. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: March 29, 2019
• Est. primary completion date: March 1, 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, 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
United States	Washington University	Saint Louis	Missouri

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	Likelihood of being concussed	Sensitivity and specificity forthe identification of the likelihood of concussion/mTBI at the time of injury using a multi-modal EEG-based Concussion Index (CI)	6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Secondary	Significance of change over time	Significant difference in concussion index between time of injury and return to play (RTP)	6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Secondary	Prediction of prolonged recovery	Accuracy of prediction of prolonged recovery from injury assessment using a multi-modal EEG-based concussion index	6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP