Back to resultsBilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM (LATESTIM)
Primary Purpose
Central Nervous System Disease, Basal Ganglia Disease, Movement Disorders
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT)
Best medical treatment
Sponsored by
About this trial
This is an interventional supportive care trial for Central Nervous System Disease focused on measuring Parkinson Disease, Morbus Parkinson, Basal Ganglia, Pallidal 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]
Presence of at least one of the following absolute exclusion criteria for STN stimulation:
- 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]
or presence of at least two of the following relative exclusion criteria for STN stimulation:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Inselspital University Hospital Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GPi DBS and best medical treatment
Best medical treatment
Arm Description
Outcomes
Primary Outcome Measures
Difference of change of the score of the Parkinson's disease questionnaire 39 (PDQ-39-SI) from baseline to follow-up between the two treatment groups.
Difference of change in number of hours per day spent in motor "on" without troublesome dyskinesia from baseline to follow-up between the two treatment groups.
Secondary Outcome Measures
Difference of change of the score of the MDS-UPDRS part III (Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale, part III) from baseline to follow up between the two trial groups.
Difference of change of the score of the MDS-UPDRS part IV (Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale, part IV) (MDS-UPDRS) from baseline to follow up between the two trial groups.
Difference of change in number of hours per day spent in motor "on" with troublesome dyskinesia from baseline to follow-up between the two treatment groups.
Full Information
NCT ID
NCT02823158
First Posted
April 18, 2016
Last Updated
October 19, 2019
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02823158
Brief Title
Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM
Acronym
LATESTIM
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
not enough patients
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Boston Scientific Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Disease, Basal Ganglia Disease, Movement Disorders, Neurodegenerative Disorders, Parkinson Disease
Keywords
Parkinson Disease, Morbus Parkinson, Basal Ganglia, Pallidal Stimulation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GPi DBS and best medical treatment
Arm Type
Experimental
Arm Title
Best medical treatment
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT)
Other Intervention Name(s)
Bilateral pallidal stimulation, Deep brain stimulation
Intervention Description
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
Intervention Name(s)
Best medical treatment
Intervention Description
Patients will receive optimized medical treatment according to published evidence based guidelines.
Primary Outcome Measure Information:
Title
Difference of change of the score of the Parkinson's disease questionnaire 39 (PDQ-39-SI) from baseline to follow-up between the two treatment groups.
Time Frame
Baseline and 5 months +/- 1 month
Title
Difference of change in number of hours per day spent in motor "on" without troublesome dyskinesia from baseline to follow-up between the two treatment groups.
Time Frame
Baseline and 5 months +/- 1 month
Secondary Outcome Measure Information:
Title
Difference of change of the score of the MDS-UPDRS part III (Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale, part III) from baseline to follow up between the two trial groups.
Time Frame
Baseline and 5 months +/- 1 month
Title
Difference of change of the score of the MDS-UPDRS part IV (Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale, part IV) (MDS-UPDRS) from baseline to follow up between the two trial groups.
Time Frame
Baseline and 5 months +/- 1 month
Title
Difference of change in number of hours per day spent in motor "on" with troublesome dyskinesia from baseline to follow-up between the two treatment groups.
Time Frame
5 months +/- 1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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]
Presence of at least one of the following absolute exclusion criteria for STN stimulation:
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]
or presence of at least two of the following relative exclusion criteria for STN stimulation:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Schüpbach, PD Dr. med
Organizational Affiliation
Inselspital University Hospital Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ines Debove, Dr. med
Organizational Affiliation
Inselspital University Hospital Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM
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