Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation

NCT02835274 | Completed Results

• 1 other identifier: A4150
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 3

Brief Summary

The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.

Conditions

Parkinson Disease

Keywords

parkinson disease; deep brain stimulation; directional stimulation

Outcome Measures

Primary Outcomes (1)

• Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase

  Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state

  Up to 12 months post-implant

Study Arms (2)

Ring mode followed by Unrestricted mode

EXPERIMENTAL

omni-directional stimulation followed by unrestricted Mode stimulation

Device: BSC Deep Brain Stimulation System with Directional Lead

Unrestricted mode followed by ring mode

ACTIVE COMPARATOR

Unrestricted Mode stimulation followed by omni-directional stimulation

Device: BSC Deep Brain Stimulation System with Directional Lead

Interventions

BSC Deep Brain Stimulation System with Directional Lead DEVICE

Ring mode followed by Unrestricted mode; Unrestricted mode followed by ring mode

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia.
• UPDRS III score of \>25 in the meds OFF condition
• Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score

You may not qualify if:

• Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator
• Any current drug or alcohol abuse as determined by the investigator
• Any history of recurrent or unprovoked seizures
• Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<12 months

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

CHU Grenoble - Hopital Michallon

Grenoble, France

Location

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Location

Academisch Medisch Centrum

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Director of Clinical Sciences
• Organization: Boston Scientific

roshini.jain@bsci.com

6619494350

Study Officials

• Roshini Jain

  Boston Scientific Neuromodulation Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 18, 2016
• Study Start: July 19, 2016
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: November 19, 2020
• Results First Posted: February 7, 2020

Record last verified: 2020-11

Locations

NL (1); DE (1); FR (1)