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

• United Kingdom

Medical Research Council

881372.78

01-10-2003

96

• Parkinson’s disease

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.

• Clinical research