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

October 19, 2019 updated by: University Hospital Inselspital, Berne

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • InselSpital University Hospital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GPi DBS and best medical treatment
Procedure: 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.

Other Names:
  • Bilateral pallidal stimulation
  • Deep brain stimulation
Procedure: Best medical treatment
Patients will receive optimized medical treatment according to published evidence based guidelines.
Active Comparator: Best medical treatment
Procedure: Best medical treatment
Patients will receive optimized medical treatment according to published evidence based guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and 5 months +/- 1 month
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
Baseline and 5 months +/- 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and 5 months +/- 1 month
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
Baseline and 5 months +/- 1 month
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
5 months +/- 1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Michael Schüpbach, PD Dr. med, InselSpital University Hospital Bern
  • Principal Investigator: Ines Debove, Dr. med, InselSpital University Hospital Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimate)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 19, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-000334

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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