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NCT04571112: 2T-DBS

GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment

Completed NA Last updated 2 November 2022
What this trial tests

NA trial testing NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US) in Parkinson Disease in 6 participants. Completed in 1 March 2021.

Timeline
4 December 2017
Primary endpoint
1 October 2020
1 March 2021

Quick facts

Lead sponsorUniversity of Toronto
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment6
Start date4 December 2017
Primary completion1 October 2020
Estimated completion1 March 2021
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of Toronto

Who can join

Eligibility, any sex, with Parkinson Disease or Memory Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Treatment of Parkinson's Disease with Cognitive Impairment: Current Approaches and Future Directions.
    Sun C, Armstrong MJ. · · 2021 · cited 50× · PMID 33920698 · DOI 10.3390/bs11040054
  2. Electrical stimulation of the nucleus basalis of meynert: a systematic review of preclinical and clinical data.
    Nazmuddin M, Philippens IHCHM, van Laar T. · · 2021 · cited 25× · PMID 34083732 · DOI 10.1038/s41598-021-91391-0

Verify or expand the search:

Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

Other University of Toronto trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04571112.

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