CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04571112
NCT04571112N/ACompleted
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Multi-targets, Single-lead GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment

University of Toronto·interventional·Posted Sep 30, 2020·Updated Nov 2, 2022

In Brief

A clinical study evaluating NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US) for Parkinson Disease and Memory Disorders. Completed, enrolled 6 participants across 1 site.

Detailed Summary

This study examines the safety and feasibility of DBS in treating the movement and cognitive dysfunction in Parkinson's disease (PD). Globus pallidus interna (GPi) stimulation is an established treatment for the motor symptoms in PD, but it does not treat the cognitive symptoms that can also be seen in this condition. It is theorized that we can improve cognitive dysfunction by stimulating a part of the brain called the nucleus basalis of Meynert (NBM), which releases a chemical (acetylcholine) and plays a role in memory and attention. By using a novel DBS system (Vercise device) with 2 electrodes that are designed to stimulate the GPi and NBM, we can potentially target the motor and cognitive symptoms of PD with a single intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease, Memory Disorders
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 30, 2020
Enrollment StartDec 4, 2017
Primary CompletionOct 1, 2020
Study CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.8 years ago

Interventions

NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)device

This will either be turned on or off depending on the arm which the patient is randomized to. After 8-weeks, the subject will switch arms for another 8-weeks.