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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06013566




Registration number
NCT06013566
Ethics application status
Date submitted
22/08/2023
Date registered
28/08/2023

Titles & IDs
Public title
SSVEP Evaluation of Brain Function (PRO)
Scientific title
SSVEP Evaluation of Brain Function (PRO)
Secondary ID [1] 0 0
2018-10-891-PRO
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Traumatic Brain Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - SSVEP

Baseline - This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season

Concussed - This cohort contains individuals who have had a concussion, diagnosed by a doctor.

Suspected Concussion - This cohort contains individuals suspected of having a concussion, but were cleared by a medical professional and do not have a concussion.


Treatment: Devices: SSVEP
Non-invasive, non-interventional SSVEP EEG device
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Steady State Visual Evoked Potential
Timepoint [1] 0 0
5 days
Secondary outcome [1] 0 0
Recovery from m TBI
Timepoint [1] 0 0
30 days

Eligibility
Key inclusion criteria
* Individuals aged 12 years and older, participating in sport-related activities.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Individuals are excluded if they have a history of seizures, history of epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights.

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
1/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Headsafe - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Headsafe MFG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Craig Donaldson, MBBS
Address 0 0
Principal Investigator
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dylan Mahony
Address 0 0
Country 0 0
Phone 0 0
+61 430 411 438
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06013566