Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000094774
Ethics application status
Approved
Date submitted
23/01/2013
Date registered
24/01/2013
Date last updated
24/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Sports-related concussion and its correlates among current and retired professional rugby league players
Scientific title
Effects of sports related concussion on the cognitive, psychological and neurological health of current and former professional rugby league players with outcomes measured via neuropsychological assessment, psychological questionnaires and sophisticated magnetic resonance imaging techniques
Secondary ID [1] 281802 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sports concussion 288129 0
Condition category
Condition code
Neurological 288507 288507 0 0
Other neurological disorders
Injuries and Accidents 288544 288544 0 0
Other injuries and accidents
Mental Health 288545 288545 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Recruitment will occur on a rolling basis over a 12-18 month period. The local professional National Rugby League club will be sought to supply current professional players. The club's 'old boys' (alumni) will be sought for retired player recruitment.

Players will be initially contacted via club officials and then contact will be made by the chief investigator to the players to provided study information and obtain consent. Once consent is obtained each participant will be requested to complete three sessions; (1) neuropsychological assessment, (2) neurological exam, olfactory stress testing and APOE genotyping, and (3) Neuroimaging. The three session will be conducted with each participant once at baseline and then again on one occassion at an eighteen month follow up. Each of the three sessions will be completed within three weeks of one another at each time point.

A 2-hour neuropsychological assessment, which involves clinical background including demographic information, educational and learning history, playing history, concussion history, drug use history, family medical history, and general medical history, in addition to the administration of psychological questionnaires and behavioural measures including the depression, anxiety stress scale (DASS), the alcohol use disorders identification test (AUDIT), the Barrett Impulsivity scale, the sports competativeness scale, along with cognitive and balance/postural stability testing will be conducted with each participant.

A one hour session including neurological examination, olfactory stress testing (OST) and buccal swab (ApoE genotyping) will also form part of the requirements. For the OST, 20 items of the UPSIT (UPSIT-20) are initially administered to the left nostril (with the right nostril occluded by a wad of cotton wool) after which 1 mg of atropine (0.1ml of 10mg/ml solution) is sprayed high into the left nostril. The patient then adopts a crouching head down position for one minute (the ‘Mecca Position’) to retain the spray. The remaining 20 items of the UPSIT are administered 40–45 min later through the left nostril, again with the right nostril occluded. The change in UPSIT score from baseline to post atropine, or ‘atropine effect’ (AE), represents an objective measure of the impact of atropine on olfactory functioning.

The third component, MRI scanning (60-mins) will involve techniques such as the standard structural MRI (three-plane localiser), MP-RAGE (volumetrics), diffusion tensor imaging (DTI), susceptability weighted imaging (SWI), magnetic resonance spectroscopy (MRS) and pulse-wave encephalopathy. Result of each component will be correlated with concussion exposure data.
Intervention code [1] 286347 0
Not applicable
Comparator / control treatment
A control group of local healthy and active non-collision sports athletes (such as cyclists and runners without a history of falls and head injury/concussion) will be recruited to form the control group for comparison. Control participants will be matched for age and education and will not have a history of concussion, learning disorder or any other neurological conditions.
Control group
Active

Outcomes
Primary outcome [1] 288663 0
Neuropsychological testing of cognitive abilities; including processing and motor speed, attention and concentration, learning and memory, inhibitory control, planning and organisation, confrontation naming and abstract reasoning (objective cognitive performance). Measured using standardised neuropsychological tests: the Rey Auditory Verbal Learning Test (RAVLT), Rey Osterrieth Complex Figure Test (ROCFT), the Wechsler Adult Intelligence Scale (WAIS) 4th edition subtests digit span, coding, symbol search, similarities, Advanced Clinical Solutions - premorbid estimate, Wechsler Adult Memory Scale (WMS) 3rd edition, information and orientation subtest, trail making test A & B, stroop test, Controlled Oral Word Association Test (COWAT), Boston Naming Test, clock drawing test, grooved pegboard test, the Balance Error Scoring System (BESS) and a computerised neuropsychological test battery CogSport.
Timepoint [1] 288663 0
Initially at baseline with follow up review conducted 12-18 months post-baseline assessment to monitor for deterioration in function.
Primary outcome [2] 288664 0
Neuroimaging data (objective neurological integrity). Measured using MRI scanner via the techniques of: standard structural MRI (three-plane localiser), MP-RAGE (volumetrics), diffussion tensor imaging (DTI), susceptability weighted imaging (SWI), magnetic resonance spectroscopy (MRS) and pulse-wave encephalopathy.
Timepoint [2] 288664 0
Initially at baseline with follow up review conducted 12-18 months post-baseline assessment to monitor for deterioration in function.
Primary outcome [3] 288665 0
Psychological & Behavioural Measures, measured using the Depression, Anxiety, Stress Scale (DASS), Frontal Systems Behavior Scale (FrSBe) self-rating and family-rating, Barrett Impulsivity Scale and the Sports Competitiveness Scale.
Timepoint [3] 288665 0
Initially at baseline with follow up review conducted 12-18 months post-baseline assessment to monitor for deterioration in function.
Secondary outcome [1] 300726 0
ApoE genotype collected via buccal swab for risk-factor analysis to concussive injury consequences / suceptability.
Timepoint [1] 300726 0
Obtained only once at baseline.
Secondary outcome [2] 300727 0
Drug and alcohol history (objective) Measured using the alcohol use disorders identification test (AUDIT) and drug history interview.
Timepoint [2] 300727 0
Initially at baseline with follow up review conducted 12-18 months post-baseline assessment to monitor for deterioration in function.
Secondary outcome [3] 300728 0
Dementia Rating Scales (objective measure of observed level of daily functioning) measures by the Frontotemporal Dementia Rating Scale and the IQ CODE
Timepoint [3] 300728 0
Initially at baseline with follow up review conducted 12-18 months post-baseline assessment to monitor for deterioration in function.
Secondary outcome [4] 300729 0
Olfactory Stress Test (objective measure of olfaction) as measured by the University of Pennsylvania Smell Identification Test (UPSIT) and 1 mg of atropine to stress the olfactory system.
Timepoint [4] 300729 0
Initially at baseline with follow up review conducted 12-18 months post-baseline assessment to monitor for deterioration in function.
Secondary outcome [5] 300730 0
Post concussive symptoms (objectively measure of common concussive symptoms) measured via the Rivermead Post-Concussion Questionnaire.
Timepoint [5] 300730 0
Initially at baseline with follow up review conducted 12-18 months post-baseline assessment to monitor for deterioration in function.

Eligibility
Key inclusion criteria
To be eligible males must be, or have been, a professional rugby league player who plays, or has formerly played, in the National rugby league competition. Control subjects will also be male and aged 18-years or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Men need to be clear of any other neurological conditions (aside from the potential effects of concussion), any learning disorder or attention deifict disorder.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
30/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 437 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 6202 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 286588 0
Charities/Societies/Foundations
Name [1] 286588 0
Brain Foundation
Country [1] 286588 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brain Foundation
Address
Suite 21, Regent House, 37-43 Alexander Street, Crows Nest, NSW, 2065.
Country
Australia
Secondary sponsor category [1] 285370 0
None
Name [1] 285370 0
Address [1] 285370 0
Country [1] 285370 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288662 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 288662 0
Ethics committee country [1] 288662 0
Australia
Date submitted for ethics approval [1] 288662 0
Approval date [1] 288662 0
03/06/2011
Ethics approval number [1] 288662 0
H-2011-0081

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

Contacts
Principal investigator
Name 37166 0
Dr Andrew Gardner
Address 37166 0
Neuropsychiatry Service,
Level 5 McAuley Building,
Calvary Mater Hosiptal,
Waratah, NSW, 2298
Country 37166 0
Australia
Phone 37166 0
+612 40335699
Fax 37166 0
+612 40335606
Email 37166 0
[email protected]
Contact person for public queries
Name 37167 0
Andrew Gardner
Address 37167 0
Neuropsychiatry Service,
Level 5 McAuley Building,
Calvary Mater Hosiptal,
Waratah, NSW, 2298
Country 37167 0
Australia
Phone 37167 0
+612 40335699
Fax 37167 0
+612 40335606
Email 37167 0
[email protected]
Contact person for scientific queries
Name 37168 0
Andrew Gardner
Address 37168 0
Neuropsychiatry Service,
Level 5 McAuley Building,
Calvary Mater Hosiptal,
Waratah, NSW, 2298
Country 37168 0
Australia
Phone 37168 0
+612 40335699
Fax 37168 0
+612 40335606
Email 37168 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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