A large randomised long-term assessment of the relative effectiveness of surgery for Parkinson's Disease (PD)
| ISRCTN | ISRCTN34111222 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34111222 |
| Secondary identifying numbers | G9900797 |
- Submission date
- 02/05/2001
- Registration date
- 02/05/2001
- Last edited
- 11/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Professor AC Williams
Scientific
Scientific
Department of Clinical Neurology
University of Birmingham
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Available in http://www.pdsurg.bham.ac.uk/documents/PISV4appd.pdf |
| Scientific title | |
| Study acronym | PD SURG |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/2001 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 400-600. Closed to recruitment - in follow-up |
| Key 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'. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Clinical Neurology
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.bham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2010 | Yes | No |
