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Trial registered on ANZCTR


Registration number
ACTRN12610000369022
Ethics application status
Approved
Date submitted
4/05/2010
Date registered
10/05/2010
Date last updated
24/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Nutritional status in Parkinson’s disease pre- and post-deep brain stimulation surgery
Scientific title
Nutritional status in Parkinson’s disease pre- and post-deep brain stimulation surgery
Secondary ID [1] 251686 0
nil
Universal Trial Number (UTN)
U1111-1114-8766
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 257281 0
Condition category
Condition code
Neurological 257428 257428 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exposure: Deep brain stimulation surgery of the sub-thalamic nucleus: This involves the stereotactic implantation of stimulating electrodes in the sub-thalamic nucleus of the brain. Implanted stimulating electrodes are routed subcutaneously and connected to a permanently implanted stimulating device usually fixed within the pectoral or rectus abdominus fascia.
The entire process takes 5 to 7 hours; the surgery generally takes 3 to 4 hours.
Intervention code [1] 256437 0
Not applicable
Comparator / control treatment
Best medical therapy: Dopamine replacement therapy (DRT) which provides substantial therapeutic relief.
Control group
Active

Outcomes
Primary outcome [1] 258349 0
Nutritional status using 4 compartment body composition analysis, the Patient-Generated Subjective Global Assessment (PG-SGA), weight, Body Mass Index (BMI)
Timepoint [1] 258349 0
Pre-surgery, 3 months post-surgery, 6 months post-surgery for the Parkinson's disease deep-brain stimulation group; baseline, 3 months post-baseline, 6 months post-baseline for control groups with continuing therapy as determine by their treating neurologist/physician
Secondary outcome [1] 264082 0
Quality of life using the Parkinson's disease questionnaire (PDQ-39)
Timepoint [1] 264082 0
Pre-surgery, 3 months post-surgery, 6 months post-surgery for the Parkinson's disease deep-brain stimulation group; baseline, 3 months post-baseline, 6 months post-baseline for control groups with continuing therapy as determine by their treating neurologist/physician

Eligibility
Key inclusion criteria
Deep brain stimulation (DBS) Parkinson's disease (PD) group (DBS-PD): diagnosis of idiopathic Parkinson's disease, scheduled for deep brain stimulation of the sub-thalamic nucleus.

Parkinson's disease control group: diagnosis of idiopathic Parkinson's disease, not scheduled for deep brain stimulation; age, gender, disease duration matched to DBS-PD participants

Elderly control group: no diagnosis of idiopathic Parkinson's disese; age and gender matched to DBS-PD participants
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgery for Parkinson's disease; unable to provide informed consent; presence of a co-morbidity (unstable cardiovascular disease, heart failure, liver failure, chronic kidney disease requiring dialysis, cancer, human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), chronic obstructive pulmonary disease) or acute illness which could influence the presence of nutrition impact symptoms and/or nutritional status

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256905 0
Self funded/Unfunded
Name [1] 256905 0
Country [1] 256905 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Road
Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 256177 0
None
Name [1] 256177 0
Address [1] 256177 0
Country [1] 256177 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258914 0
Uniting Care Health Human Research Ethics Committee
Ethics committee address [1] 258914 0
Ethics committee country [1] 258914 0
Australia
Date submitted for ethics approval [1] 258914 0
Approval date [1] 258914 0
17/03/2010
Ethics approval number [1] 258914 0
1013

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

Contacts
Principal investigator
Name 31120 0
Address 31120 0
Country 31120 0
Phone 31120 0
Fax 31120 0
Email 31120 0
Contact person for public queries
Name 14367 0
Jamie Sheard
Address 14367 0
Queensland University of Technology
Institute of Health and Biomedical Innovation
60 Musk Ave
Kelvin Grove, QLD 4059
Country 14367 0
Australia
Phone 14367 0
+61731386183
Fax 14367 0
Email 14367 0
jamie.sheard@qut.edu.au
Contact person for scientific queries
Name 5295 0
Jamie Sheard
Address 5295 0
Queensland University of Technology
Institute of Health and Biomedical Innovation
60 Musk Ave
Kelvin Grove, QLD 4059
Country 5295 0
Australia
Phone 5295 0
+61731386183
Fax 5295 0
Email 5295 0
jamie.sheard@qut.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.