Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000503426
Ethics application status
Approved
Date submitted
1/10/2007
Date registered
4/10/2007
Date last updated
4/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rehabilitation of attention following traumatic brain injury: A model for methylphenidate
Scientific title
Rehabilitation of attention following traumatic brain injury: A model for methylphenidate
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 2411 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2517 2517 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Methylphenidate hydrochloride.
Oral administration of compounded product in opaque gelatin capsules identical to comparator.
Dose 0.3 mg/kg twice daily (8am & 12pm).
There are 6 trial days (Mon, Wed, Fri) over a two week period. The 6 sessions are divided into three blocks: Days 1 & 2, Days 3 & 4, Days 5 & 6. One session of each block is randomly assigned as a methylphenidate session and the other as a placebo session. The methylphenidate & placebo are each administered on 3 out of the 6 trial days.
Intervention code [1] 2133 0
Treatment: Drugs
Intervention code [2] 2134 0
Rehabilitation
Comparator / control treatment
Lactose as placebo.
Oral administration of compounded product in opaque gelatin capsules identical to comparator.
Dose 0.3 mg/kg twice daily (8am & 12pm).
There are 6 trial days (Mon, Wed, Fri) over a two week period. The 6 sessions are divided into three blocks: Days 1 & 2, Days 3 & 4, Days 5 & 6. One session of each block is randomly assigned as a methylphenidate session and the other as a placebo session. The methylphenidate & placebo are each administered on 3 out of the 6 trial days.
Control group
Active

Outcomes
Primary outcome [1] 3411 0
Reaction time on computerised visuo-spatial choice RT tasks
Timepoint [1] 3411 0
On the 6 trial days over the 2 week period
Primary outcome [2] 3412 0
Performance on standardised neuropsychological measures:
Symbol Digit Modalities Test,
Ruff 2 & 7 Selective Attention Test,
Letter Number Sequencing (from WAIS-III)
Timepoint [2] 3412 0
On the 6 trial days over the 2 week period
Primary outcome [3] 3413 0
Score on the Rating Scale of Attentional Behaviour as rated by Allied Health Therapists
Timepoint [3] 3413 0
On the 6 trial days over the 2 week period
Secondary outcome [1] 5674 0
Measurement of drug effects on vital signs:
pulse, blood pressure, mean arterial pressure
Timepoint [1] 5674 0
On the 6 trial days over the 2 week period
Secondary outcome [2] 5675 0
Measurement of drug effects on Side Effects Monitoring Form
Timepoint [2] 5675 0
On the 6 trial days over the 2 week period

Eligibility
Key inclusion criteria
-History of moderate-severe traumatic brain injury sustained within the previous 12 months
-Current inpatient on Acquired Brain Injury (ABI) ward of Epworth Rehabilitation
-Demonstrated attentional impairment as indicated on the Symbol Digit Modalities Test
-Adequate physical and cognitive abilities and understanding of English to complete neuropsychological tasks
Minimum age
16 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Past neurological history
-Past treatment for drug/alcohol dependence
-Current treatment with psychoactive medications likely to interact with methylphenidate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutive admissions to the ABI ward at Epworth Rehabilitation were screened for suitability to participate in the study. Those eligible were asked if they wished to participate in the trial by their treating physician. Once patients had given informed written consent the investigator was contacted and provided with patient details. The trial investigator then contacted the holder of the allocation schedule for methylphenidate/placebo randomisation who was based in the hospital pharmacy (not part of the rehabilitation team), and the patient's trial randomisation was allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation was employed for subject randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 441 0
3121

Funding & Sponsors
Funding source category [1] 2663 0
Government body
Name [1] 2663 0
Victorian Neurotrauma Initiative
Country [1] 2663 0
Australia
Funding source category [2] 2664 0
Charities/Societies/Foundations
Name [2] 2664 0
The Wenkart Foundation
Country [2] 2664 0
Australia
Primary sponsor type
Individual
Name
Ms. Catherine Willmott
Address
c/o Monash-Epworth Rehabilitation Research Centre
Epworth Hospital
89 Bridge Road
Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 2409 0
Individual
Name [1] 2409 0
Professor Jennie Ponsford
Address [1] 2409 0
c/o Monash-Epworth Rehabilitation Research Centre
Epworth Hospital
89 Bridge Road
Richmond VIC 3121
Country [1] 2409 0
Australia
Other collaborator category [1] 62 0
Hospital
Name [1] 62 0
Epworth Hospital
Address [1] 62 0
89 Bridge Road
Richmond VIC 3121
Country [1] 62 0
Australia
Other collaborator category [2] 63 0
University
Name [2] 63 0
Monash University
Address [2] 63 0
Wellington Road
Clayton VIC 3800
Country [2] 63 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4583 0
Human Research & Ethics Committe
Ethics committee address [1] 4583 0
Epworth Hospital
89 Bridge Road
Richmond VIC 3121
Ethics committee country [1] 4583 0
Australia
Date submitted for ethics approval [1] 4583 0
01/06/2003
Approval date [1] 4583 0
25/06/2003
Ethics approval number [1] 4583 0
24203
Ethics committee name [2] 4584 0
Standing Committee on Ethics and Research involving Humans
Ethics committee address [2] 4584 0
Monash University
Wellington Road
Clayton VIC 3800
Ethics committee country [2] 4584 0
Australia
Date submitted for ethics approval [2] 4584 0
15/06/2003
Approval date [2] 4584 0
05/08/2003
Ethics approval number [2] 4584 0
2003/530 MC

Summary
Brief summary
Traumatic brain injury (TBI) results in disabling impairments of attention and speed of information processing, which prevent patients from returning to previous life roles. Methylphenidate primarily acts upon dopaminergic and noradrenergic neurotransmitter systems which mediate attentional processes, and are disrupted by TBI. Previous treatment study findings with methylphenidate have been mixed, and many have recruited patients many years post-injury. This study aims to investigate the efficacy of methylphenidate in the amelioration of attention deficits during the acute rehabilitation phase. Forty participants with TBI and 40 healthy controls were seen for a one-off two hour baseline assessment session in order to identify the nature of attentional impairment following TBI. The TBI group were then recruited into the randomised, crossover, placebo controlled drug trial of two weeks duration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28080 0
Address 28080 0
Country 28080 0
Phone 28080 0
Fax 28080 0
Email 28080 0
Contact person for public queries
Name 11237 0
Ms Catherine Willmott
Address 11237 0
c/o Monash-Epworth Rehabilitation Research Centre
Epworth Hospital
89 Bridge Road
Richmond VIC 3121
Country 11237 0
Australia
Phone 11237 0
0413545495
Fax 11237 0
Email 11237 0
[email protected]
Contact person for scientific queries
Name 2165 0
Ms Catherine Willmott
Address 2165 0
c/o Monash-Epworth Rehabilitation Research Centre
Epworth Hospital
89 Bridge Road
Richmond VIC 3121
Country 2165 0
Australia
Phone 2165 0
0413545495
Fax 2165 0
Email 2165 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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