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Patients in the GPi group will be implanted with DBS-electrodes within 6 weeks after randomisation. The stimulation parameters and the medical treatment are adjusted for optimal control of motor and non-motor signs and symptoms according to published guidelines using a specified algorithm. The stimulation parameters are recorded at the beginning and at the end of each post-surgical assessment.

Best medical treatment is applied in combination with GPi-DBS.

Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT)

Patients will receive optimized medical treatment according to published evidence based guidelines.

Best medical treatment

Michael Schüpbach, PD Dr. med

Ines Debove, Dr. med

Deep brain stimulation (DBS) is an established treatment for advanced complicated Parkinson's disease (PD). Several controlled randomized studies have given proof of an advantage for operated patients as compared to medically treated patients in terms of motor outcome, activities of daily living and health status. However these studies have addressed mostly stimulation of the subthalamic nucleus (STN). GPi stimulation has not been compared to best medical treatment (BMT) in a prospective randomized controlled trial in patients with complicated PD who are not good candidates for STN stimulation. The investigators aim assessing GPi-DBS in patients with PD who have contraindications for STN-DBS.

The indication and excellent therapeutic effects of STN stimulation have been sufficiently proven in advanced PD, and the contraindications for this treatment are rather well established. Also, the observation that patients fulfilling the "STN-profile" but who had been operated for pallidal DBS and lost part of the treatment's benefit over time, improved when stimulated later in the STN (instead of the GPi) shows that patients qualifying for STN-DBS do not have as good a result with GPi-DBS.

GPi stimulation may be used in patients who do not qualify for STN stimulation. Especially postural instability, age over 70 years, and mild to moderate cognitive deficits are commonly considered to be exclusion criteria for STN stimulation but not for GPi stimulation. Therefore, the investigators propose a prospective randomized controlled trial of GPi stimulation in patients with PD and motor complications who have relative or absolute contraindications for STN stimulation.

Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM

A Prospective Randomized Controlled Trial of Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease With Motor Complications and Relative or Absolute Contraindications for Subthalamic Stimulation

Boston Scientific Corporation

Insel Gruppe AG, University Hospital Bern

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM	NCT02823158	Central Nervous... Basal Ganglia D... Movement Disord... Neurodegenerati... Parkinson Disea...	Deep brain stim... Best medical tr...	18 Years - 85 Years	Insel Gruppe AG, University Hospital Bern
Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM	NCT02823158	Central Nervous... Basal Ganglia D... Movement Disord... Neurodegenerati... Parkinson Disea...	Deep brain stim... Best medical tr...	18 Years - 85 Years	Insel Gruppe AG, University Hospital Bern

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