Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03710109


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT03710109
Ethics application status
Date submitted
15/10/2018
Date registered
17/10/2018
Date last updated
19/01/2023

Titles & IDs
Public title
Evaluation of an EEG Based Concussion System
Scientific title
Evaluation of an EEG Based Concussion System
Secondary ID [1] 0 0
GCO 18-0699
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - EEG

Concussion - Individuals who have sustained a recent concussion

Control Healthy Volunteers - No Intervention


Other interventions: EEG
non-invasive, non-interventional sensor
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Steady State Visual Evoked Potential
Timepoint [1] 0 0
up to 28 days

Eligibility
Key inclusion criteria
- Individuals seeking medical care Mount Sinai Hospital after sustaining a possible
concussion.

- Healthy Individuals with no recent history of head trauma
Minimum age
9 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Known history of epilepsy or any other seizure disorder

- Legally blind

- Reduced capacity to consent if there is not a Legally Authorized Representative (LAR)
present

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2023
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York

Funding & Sponsors
Primary sponsor type
Other
Name
Icahn School of Medicine at Mount Sinai
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the accuracy of a new concussion system at detecting concussions.
The investigators will be evaluating the degree to which data collected with the device
agrees with a physician's determination of a concussion. The system captures an
electroencephalograph (EEG) potential when a light is flashed into the eyes of an individual.
The device is not FDA approved, but it is a non-significant risk device. The device is a
non-invasive, non-interventional sensor. It will not replace the opinion of the physician in
diagnosing a concussion.

This study will test the EEG based concussion system on 200 individuals, Participants will be
made up of individuals who are seeking medical consultation at the Play Safe Concussion
Clinic (10 Union Square E, New York, NY 10003) or at Mount Sinai Hospital (1468 Madison Ave,
New York, NY 10029) after experiencing a head trauma. The Play Safe Clinic treats patients
who reach out to Mount Sinai Physicians via the Play Safe telephone number: 212 241 2221. The
doctors who see patients these locations will be involved in conducting this research. In
addition to the standard-of-care clinical assessments, participants will also receive an
evaluation from the concussion based system.

When a subject experiences a head trauma, the subject will be evaluated for a concussion by
both the standard-of-care clinical assessments. The treating physician will provide all
necessary standard-of-care evaluations and diagnostic procedures needed to properly diagnose
and treat each patient and by the new concussion system. The researchers will also collect
data from healthy, age-matched controls in order to collect a database of healthy responses
to the technology.

To determine how accurate the new concussion system is at detecting concussions, the research
team will compare the diagnostic results from the device to the diagnostic results of the
doctor's assessments. The goal of this study is to develop a device that can give sound
advice as to whether an individual should seek medical attention for a possible concussion
following a head injury.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03710109
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
David Putrino, PT, PhD
Address 0 0
Icahn School of Medicine at Mount Sinai
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Aidan Rogers, MS
Address 0 0
Country 0 0
Phone 0 0
212-824-8369
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03710109

Additional trial details provided through ANZCTR
Accrual to date
60
Recruiting in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 14
2086
Recruitment postcode(s) [2] 15
2627
Recruitment postcode(s) [3] 16
2015
Recruitment postcode(s) [4] 17
2022
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Headsafe
Primary sponsor address
231 Birrell St
Bronte
NSW 2024
Primary sponsor country
Australia
Other collaborator category [1] 7
Commercial sector/Industry
Name [1] 7
EBM Analytics
Address [1] 7
119 Willoughby Road, Crows Nest 2065
Country [1] 7
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 10
Bellberry
Address [1] 10
123 Glen Osmond Road Eastwood Adelaide South Australia 5063
Country [1] 10
Australia
Date submitted for ethics approval [1] 10
24/10/2018
Approval date [1] 10
06/02/2019
Ethics approval number [1] 10
2018-10-891-A-3
 
Public notes
The ANZ arm of this study is a multicentre prospective observational study, with recruitment sites across New South Wales approved by Bellberry Ltd HREC (Ref: HREC2018-10-891). Key protocol details particular to the ANZ arm of the study are highlighted below;

Eligibility
Minimum age for inclusion - 14 years at time of consent
Key Inclusion Criteria:
- Individuals seeking medical care at an approved site after sustaining a suspected concussion
- Individuals participating in sports/activities at risk of head trauma, with no recent history of concussion or head trauma

Sample size Target - 100 concussion cases; 400 baseline assessments

Accuracy of the concussion system will be assessed by comparing the results recorded from the device to the diagnostic results of the licensed medical professional assessing the patient at the time, as well as the results of the King Devick clinical concussion assessment.

Contacts
Principal investigator
Title 97 0
Dr
Name 97 0
Craig Donaldson
Address 97 0
13/139 Macquarie St, Sydney NSW 2000
Country 97 0
Australia
Phone 97 0
(02) 9241 2913
Fax 97 0
Email 97 0
[email protected]
Contact person for public queries
Title 98 0
Dr
Name 98 0
Adrian Cohen
Address 98 0
231 Birrell St Bronte Nsw 2024
Country 98 0
Australia
Phone 98 0
02 8007 3903
Fax 98 0
Email 98 0
[email protected]
Contact person for scientific queries
Title 99 0
Dr
Name 99 0
Craig Donaldson
Address 99 0
13/139 Macquarie St, Sydney NSW 2000
Country 99 0
Australia
Phone 99 0
(02) 9241 2913
Fax 99 0
Email 99 0
[email protected]