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 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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [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
While it is known that patients with Parkinson’s disease (PD) lose more weight and have a higher risk of decreased bone mineral density and increased inflammation when compared with age-matched controls, and deep brain stimuation of the subthalamic nucleus (STN-DBS surgery) in PD is followed by weight gain, there has been limited research that has investigated specific factors that impact upon nutritional status in PD. There has also been limited research in regards to the measurement of nutritional status in Parkinson’s disease.
The overall aim of this project is to determine the influence of motor and non-motor symptoms and inflammation on nutritional status in people with Parkinson’s disease and how deep-brain stimulation modifies the severity of symptoms and inflammation and therefore their impact on nutritional status.
The specific aims of the proposed project are to:
*Identify potential factors influencing nutritional status changes in Parkinson’s disease.
*Evaluate the effectiveness of available subjective and objective tools in the assessment of nutritional status in Parkinson’s disease.
*Provide evidence to inform effective nutritional interventions aiming to address the decline in nutritional status associated with Parkinson’s disease.
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
Summary results
No Results