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ISRCTN
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ISRCTN34111222
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DOI
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10.1186/ISRCTN34111222
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A large randomised long-term assessment of the relative effectiveness of surgery for Parkinson's Disease (PD)
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Scientific title
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Acronym
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PD SURG
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Serial number at source
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G9900797
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Neurosciences, psychiatry
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Participants - inclusion criteria
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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'.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/10/2001
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Anticipated end date
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30/09/2011
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Status of trial
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Completed |
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Patient information material
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Available in http://www.pdsurg.bham.ac.uk/documents/PISV4appd.pdf
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Target number of participants
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400-600. Closed to recruitment - in follow-up
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Interventions
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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)
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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.
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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http://www.pdsurg.bham.ac.uk/
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20434403
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Contact name
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Professor
AC
Williams
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Address
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Department of Clinical Neurology
University of Birmingham
Queen Elizabeth Hospital
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TH
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Country
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United Kingdom
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Email
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Sponsor
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University of Birmingham (UK)
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Address
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Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Email
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Sponsor website:
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http://www.bham.ac.uk/
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Date applied
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02/05/2001
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Last edited
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11/06/2010
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Date ISRCTN assigned
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02/05/2001
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