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

NCT ID: NCT02823158

Last Updated: 2019-10-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Central Nervous System Disease; Basal Ganglia Disease; Movement Disorders; Neurodegenerative Disorders; Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

GPi DBS and best medical treatment

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

Best medical treatment

Intervention Type: PROCEDURE

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

Best medical treatment

Group Type: ACTIVE_COMPARATOR

Best medical treatment

Intervention Type: PROCEDURE

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

Interventions

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

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.

Intervention Type: PROCEDURE

Best medical treatment

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

Intervention Type: PROCEDURE

Other Intervention Names

Bilateral pallidal stimulation; Deep brain stimulation

Eligibility Criteria

Inclusion Criteria

• Parkinson's disease according to the UKBB criteria, with the exception that familial forms of otherwise typical parkinsonian syndromes may also be included
• motor complications of dopaminergic medication (dyskinesia or motor fluctuations or both) that are at least moderately bothersome to the patient [on a scale of 5 possible levels: not at all / mildly / moderately / severely / extremely bothersome]

Exclusion Criteria

• Mattis dementia rating scale <130 points
• postural instability of >1 in the item of MDS-UPDRS III [item #12] "on" medication
• less than 30% improvement of axial score in the acute levodopa challenge test [axial score =sum of items 3.1, 3.9, 3.10, 3.12, 3.13 of the MDS UPDRS III]

• age > 70 years
• Mattis dementia rating scale <134 points
• gait freezing "on" medication
• dysarthria of > 2 in the item of the MDS-UPDRS III [item #3.1]
• less than 50% improvement of axial score in the acute levodopa challenge test [axial score = sum of items 3.1, 3.9, 3.10, 3.12, 3.13 of the MDS UPDRS III]
• Starkstein apathy score of ≥14
• Complete baseline PDQ-39-SI and patient diary available
• written informed consent

• Age > 85 years
• surgical or medical contraindications
• abnormalities on brain MRI that preclude the implantation of electrodes into the GPi
• contraindication for 3T MRI (baseline imaging)
• severe medical illness that is likely to hamper the benefit of DBS
• severe personality disorder that may interfere with optimization of DBS
• dementia according to DSM-V and MMSE < 20
• ongoing psychosis (except pseudohallucinations)
• ongoing major depression (BDI-II > 23) or depression of any severity with suicidal ideation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Schüpbach, PD Dr. med

Role: PRINCIPAL_INVESTIGATOR

Inselspital University Hospital Bern

Ines Debove, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Inselspital University Hospital Bern

Locations

Inselspital University Hospital Bern

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

2016-000334

Identifier Type: -

Identifier Source: org_study_id