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
Abstracts are not currently available in GtR for all funded research. This is normally because the abstract was not required at the time of proposal submission, but may be because it included sensitive information such as personal details.
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.
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


Mistry S.
(2007)
Correlation of patient quality of life and a clinical rating scale in advanced Parkinson's disease (PD) - results from the PD SURG trial
in MOVEMENT DISORDERS

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

Patel S.
(2008)
The impact of surgery in Parkinson's disease on carer quality of life: Results from the PD SURG trial
in MOVEMENT DISORDERS

Patel S.
(2008)
Which patients with Parkinson's disease benefit most from surgery? Subgroup analysis from the PD SURG trial
in MOVEMENT DISORDERS

Plaha P
(2008)
Induction of parkinsonian resting tremor by stimulation of the caudal zona incerta nucleus: a clinical study.
in Journal of neurology, neurosurgery, and psychiatry

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

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

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

Rick C. E.
(2007)
Patient quality of life impacts on carer quality of life in advanced Parkinson's disease - results from 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 |