NCT04571112|CompletedFDA Device
GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment
2T-DBS
Multi-targets, Single-lead GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment
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2T-DBS
Multi-targets, Single-lead GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment
Sponsor study identifier
interventional
6
1 country
1
Study Start
December 4, 2017
Actual (reported)Primary Completion
October 1, 2020
Actual (reported)Study Completion
March 1, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 4, 2017
Actual (reported)September 12, 2019
Actual (reported)September 30, 2020
Actual (reported)October 1, 2020
Actual (reported)March 1, 2021
Actual (reported)Change in cognition after GPi/NBM DBS
This will be measured by the ADAS-Cog 13, verbal fluency test and sustained attention task.
at baseline and 6, 14, 22, 30 and 52 weeks post surgery
Change in motor function (UPDRS)GPi/NBM DBS
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive 65 item assessment of both motor and non-motor symptoms associated with Parkinson's Disease. Each symptom is rated on a 5-point scale (from 0 to 4), and the maximum total score is 199, indicating severe impairment from parkinson's disease.
at baseline and 6, 14, 22, 30 and 52 weeks post surgery
To assess the occurrence of adverse events from GPi/NBM DBS and occurrence of adverse events.
We define an adverse event (AE) as any untoward medical occurrence that occurs in the course of this study whether or not considered related to the study device, study procedures or study requirements that is identified or worsens during the study.
through study completion, an average of 1 year
To assess the impact on health-related quality-of-life and various non-motor symptoms of PD
1 year
To use neuroimaging biomarkers (MEG and FDG-PET) to examine localized effects of NBM stimulation
with NBM turned on and off, 22 and 30 weeks after surgery respectively
The post-surgical double-blind cross-over phase with randomization will follow once programming settings are determined. Under constant GPi DBS, patients will receive NBM DBS active or sham for 8 weeks followed by an 8-week cross-over. The NBM ON arm will have constant NBM stimulation for 8 weeks.
The post-surgical double-blind cross-over phase with randomization will follow once programming settings are determined. Under constant GPi DBS, patients will receive NBM DBS active or sham for 8 weeks followed by an 8-week cross-over. The NBM OFF arm will have NBM stimulation turned off for 8 weeks.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
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Alfonso Fasano, MD, PhD
University of Toronto
6 participants (actual enrollment reported by the registry).
Contact the study team to confirm eligibility.
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First Submitted
September 12, 2019
First Posted
September 30, 2020
Study Start
December 4, 2017
Actual (reported)Primary Completion
October 1, 2020
Actual (reported)Study Completion
March 1, 2021
Actual (reported)Last Updated
November 2, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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