A large randomised long-term assessment of the relative effectiveness of surgery for Parkinson's disease

Lead Research Organisation: University of Birmingham
Department Name: Unlisted

Abstract

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Technical Summary

Surgery for Parkinson‘s disease may be performed at three sites (thalamus, globus pallidum or subthalamic nucleus (STN)) using two techniques (electrical stimulation or radio frequency lesioning). There is very little reliable evidence available as to the optimal timing, site and technique. Few randomised trials have addressed these questions, and those that have been performed have been small. Most published reports relate to small non-randomised series, which can not provide reliable evidence because of the potential selection biases involved. Although surgery may produce rapid and obvious clinical improvements, it is important to evaluate the safety and long-term effects of the procedure. There is, therefore, an urgent need for large randomised trials of surgery for PD to be undertaken.

PDSURG is a randomised controlled trial that will evaluate the role of STN surgery, by either stimulation or lesioning, compared to medical therapy (with surgical intervention delayed as long as possible) in patients with advanced PD that is not controlled by their current medical treatment. Patients allocated to medical therapy will receive whatever drug treatment is considered appropriate (this may include continuous apomorphine infusion).

PDSURG is a large, simple, real-life trial. It will accrue 400 to 600 patients, and will follow them for up to 9 years, in order to obtain reliable evidence on the long-term risks and benefits of surgery. The majority of assessments will be by questionnaires to patients (and their carers) to evaluate quality of life, with some clinical evaluations in a subset of patients. An economic analysis will be a major component of the trial.

Publications

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Ottridge R. S. (2012) Implantable pulse generator lifespan in the PD SURG trial in MOVEMENT DISORDERS

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Plaha P (2011) Bilateral caudal zona incerta nucleus stimulation for essential tremor: outcome and quality of life. in Journal of neurology, neurosurgery, and psychiatry

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Plaha P (2008) Bilateral stimulation of the caudal zona incerta nucleus for tremor control. in Journal of neurology, neurosurgery, and psychiatry

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Rick C. (2010) The Use of Apomorphine in the PD SURG Trial in MOVEMENT DISORDERS

 
Description discussions with health authorities
Geographic Reach National 
Policy Influence Type Participation in a national consultation
Impact Work in Progress
 
Description Emma MacIntosh - Senior Research Fellowship
Amount £210,060 (GBP)
Organisation Parkinson's UK 
Sector Charity/Non Profit
Country United Kingdom
Start 02/2011 
End 02/2014
 
Description Medical Research Council Midland Hub for Trials Methodology Research
Amount £3,712 (GBP)
Funding ID G0800808 
Organisation Medical Research Council (MRC) 
Department Network of Hubs for Trials Methodology Research (HTMR)
Sector Academic/University
Country United Kingdom
Start 03/2012 
End 04/2012
 
Description HE anslyses for PD SURG 
Organisation University of Glasgow
Department Institute of Health and Wellbeing
Country United Kingdom 
Sector Academic/University 
PI Contribution BCTU collects all the trial data, send out queries and requests for more data where neccessary. Sections of the data, per the grant application, are anonymised and sent to collaborators who are expert in different aspects of their analysis.
Collaborator Contribution Emma McIntosh has performed the Health Economic Modelling of the PD SURG data to examine the cost-effectiveness of Deep Brain Stimulation versus medical therapy alone.
Impact First publication in preparation
 
Description PDQ-39 and SF-36 analyses PD SURG 
Organisation University of Oxford
Department Oxford Health Services Research Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution BCTU collects all the trial data, send out queries and requests for more data where neccessary. Sections of the data, per the grant application, are anonymised and sent to collaborators who are expert in different aspects of their analysis.
Collaborator Contribution undertake analyses of PD-SURG quality of life and outcomes data. In particular: 1. Explore the relationship between the Parkinson Disease Questionaire (PDQ-39) and the UPDRS clinical rating scale 2. Evaluate the relationship between patient quality of life as reported on the PDQ-39 and carer reported strain/quality of life using both cross sectional and longitudinal data. 3. Evaluate the data gained from the PDQ-39 using Rasch analyses and determine the extent to which the measure assesses unidimensional constructs.
Impact See abstracts submitted by C. Jenkinson
 
Description BBC news 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Primary Audience Media (as a channel to the public)
Results and Impact Lots of feed-back from patients

Invitations to patient groups
Year(s) Of Engagement Activity 2010
 
Description Patient Newsletter 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Participants in our clinical trials receive newsletters updating them on the progress of our research. The newsletters are also available on our websites.

Newsletters often spark requests for more information, most typically about our DNA bank. We have also started to include articles written by participants which has generated a lot of interest and responses from other participants.
Year(s) Of Engagement Activity 2009,2010,2011,2012
 
Description Presentation at Parkinson's UK meeting 
Form Of Engagement Activity Scientific meeting (conference/symposium etc.)
Part Of Official Scheme? No
Type Of Presentation Poster Presentation
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Parkinson's UK holds meetings every 2 years for researchers and patients/public to discuss updates in research in to PD.

Discussions with colleagues have lead to a meeting to look at the possibility of a new clinical trial.
Year(s) Of Engagement Activity 2008,2010,2012