L-dopa Versus Dopamine Agonists After Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
Status:
Unknown status
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
Deep Brain Stimulation (DBS) of the Subthalamic nucleus (STN) is an established treatment for
patients with advanced Parkinson's disease (PD). STN DBS improves dopaminergic
drug-responsive motor symptoms, thus allowing a reduction of post-operative drug dose.
However, a considerable variation in the extent of dopaminergic drug reduction has been
reported, with values ranging from 20% to 100%. Both L-dopa and DAs can be used, however,
there are no formal studies examining which type of antiparkinsonian medication may be more
effective and/or better tolerated following STN DBS.
Aim of our study is to compare the efficacy and the tolerability of L-dopa monotherapy versus
DAs monotherapy after STN DBS over a 3-month follow up period.
This study is a prospective, single blind parallel trial comparing L-dopa monotherapy and DAs
monotherapy after STN DBS. Patients will be enrolled in pairs, with one patient randomly
assigned to L-dopa monotherapy and the other to DA monotherapy after STN DBS (20 patients for
each study arm). Treatment assignment will be unmasked for the patient but will be blinded
for the neurologist programming DBS and evaluating the patient. Another neurologist will be
in charge of medication adjustments. Primary outcome is the change in severity of non-motor
symptoms as assessed by the Non-motor Symptoms Scale (NMSS) at 3-month follow up visit after
surgery.
In spite of an improvement of the motor condition many patients develop apathy and depression
following surgery ("Neurosurgery in Parkinson's disease: the doctor is happy, the patient
less so"). This study will shed light on the best way to manage patients after STN procedure,
thus contributing to a further improvement of the surgical outcome in a population of young
and motivated patients (those commonly receiving STN DBS), eventually bringing them closer to
a normal personal and social life.
Results of our study may provide new insights in the management of advanced PD after STN DBS,
further leading to development of future larger trials.
Phase:
Phase 2
Details
Lead Sponsor:
University of Toronto
Collaborator:
Michael J. Fox Foundation for Parkinson's Research