NCT02823158

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

2.2 years

First QC Date

April 18, 2016

Last Update Submit

October 19, 2019

Conditions

Central Nervous System DiseaseBasal Ganglia DiseaseMovement DisordersNeurodegenerative DisordersParkinson Disease

Keywords

Parkinson DiseaseMorbus ParkinsonBasal GangliaPallidal Stimulation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and 5 months +/- 1 month

Secondary Outcomes (3)

  • 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.

    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.

    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.

    5 months +/- 1 months

Study Arms (2)

GPi DBS and best medical treatment

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

Best medical treatment

ACTIVE COMPARATOR
Procedure: Best medical treatment

Interventions

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

Also known as: Bilateral pallidal stimulation, Deep brain stimulation
GPi DBS and best medical treatment
Best medical treatmentPROCEDURE

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

Best medical treatmentGPi DBS and best medical treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[on a scale of 5 possible levels: not at all / mildly / moderately / severely / extremely bothersome\]

You may not qualify if:

  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Central Nervous System DiseasesBasal Ganglia DiseasesMovement DisordersNeurodegenerative DiseasesParkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Nervous System DiseasesBrain DiseasesParkinsonian DisordersSynucleinopathies

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Michael Schüpbach, PD Dr. med

    Inselspital University Hospital Bern

    PRINCIPAL INVESTIGATOR

  • Ines Debove, Dr. med

    Inselspital University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

July 6, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations

CH(1)