Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9900797
Study information
Scientific title
Acronym
PD SURG
Study hypothesis
PD SURG will evaluate whether STN surgery has a cost-effective role in the treatment of PD and will also investigate the optimal timing of such surgery. The trial will compare surgery with active medical therapy (with surgery delayed for as long as possible) with respect to patient and carer Quality of Life (QoL), control of the symptoms of PD (short and long term), safety and costs.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Available in http://www.pdsurg.bham.ac.uk/documents/PISV4appd.pdf
Condition
Neurosciences, psychiatry
Intervention
Patients in both arms will receive active intervention:
1. In the surgery arm, Subthalamic nucleus stimulation (STN) surgery by stimulation (or possibly lesioning after the start up phase)
2. In the medical therapy arm, drugs will be prescribed as considered appropriate (this will often include continuous apomorphine)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Patient's self-evaluation of functional status (using the PDQ-39 questionnaire). It is important that the trial assesses the patients' own perceptions of their functioning and addresses matters of most concern to them. The PDQ-39 is a self-completed questionnaire, specifically developed and tested for use in clinical trials by two of the applicants/collaborators. It reflects patients' concerns in eight aspects of PD: mobility, activities of daily living, emotional well-being, stigma, social support, cognition and bodily discomfort. It has been extensively tested for validity, reproducibility and sensitivity. Affective and cognitive changes are detected by PDQ-39
Secondary outcome measures
1. Quality of life. In addition to PDQ-39, the EuroQoL EQ-5D will be used as the main outcome measure for the Health Economic evaluation (see below) as this permits incremental quality adjusted life-years (QALYs) to be calculated.
2. Dementia screen. The trial aims to determine whether therapies prevent or decrease the decline of cognitive function as measured by the DRS-II. The DRS has the ability to assess the level of cognitive impairment in different clinical populations and to differentiate between types of dementia.
3. Clinical assessment of functioning. The Unified Parkinson's Disease Rating Scale (UPDRS - both on and off drug therapy) and Hoehn & Yahr staging system will provide a standard neurological assessment against which to validate further the PDQ-39 in a subset of patients.
4. Neuropsychology. A semi-structured neuropsychiatric interview and psychometric measures of depression/anxiety, and cognition (pre-morbid/current IQ, language, attention-executive functions, memory and spatial skills) in a subset of patients.
5. Burden on carers. Little is known about the effects of PD and its treatment on carers. The person identified by the patient as their primary carer, if they have one, will be asked to complete the SF36, a well validated measure of health status.
6. Institutionalisation rates and other measures of individual and societal cost.
7. Toxicity and side-effects of surgery, including mortality, stroke and other serious adverse events. Toxicity and side-effects of medical therapy will also be recorded.
8. Death from all causes and specifically from PD and the surgical procedure. Patients will be flagged with the Office for National Statistics (ONS) for long-term mortality follow-up.
Some centres will wish to undertake additional investigations (e.g. more detailed clinical assessments, including video records, neuropsychology, physiology and imaging) and we will encourage such scientific add-on studies, although they will not be part of the main trial.
Overall trial start date
01/10/2001
Overall trial end date
30/09/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. They have PD that is not controlled by current medical therapy
2. They are considered fit enough for surgical intervention
3. They are unlikely to be considered to definitely require, and be able to receive, surgery within 1 year of entry
4. They are not demented
5. They are able to understand and complete the trial questionnaires (non-English speaking patients may be entered if they have a carer, relative or other person who can help them)
6. They have given written informed consent
Definite indications for, or contraindications against, any of the therapies in the trial are not specified by the protocol, but by the responsible clinician. Eligibility will be based on the 'uncertainty principle'.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
400-600. Closed to recruitment - in follow-up
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2001
Recruitment end date
30/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Clinical Neurology
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20434403
Publication citations
-
Results
Williams A, Gill S, Varma T, Jenkinson C, Quinn N, Mitchell R, Scott R, Ives N, Rick C, Daniels J, Patel S, Wheatley K, , Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial., Lancet Neurol, 2010, 9, 6, 581-591, doi: 10.1016/S1474-4422(10)70093-4.