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

Parkinson Disease Clinical Trial

— DIRECT-DBS  

Official title:

Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835274
• Other study ID #: A4150
• Status: Completed
• Phase: N/A
• Start date: July 19, 2016
• Est. completion date: December 19, 2018

Study information

• Verified date: November 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 19, 2018
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• BSC Deep Brain Stimulation System with Directional Lead

Locations

Country	Name	City	State
France	CHU Grenoble - Hopital Michallon	Grenoble
Germany	Universitaetsklinikum Wuerzburg	Wuerzburg
Netherlands	Academisch Medisch Centrum	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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