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Simultaneous DBS of the GPi and the NBM in Patients With Parkinson's Disease and Mild Cognitive Impairment

NCT05320523 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-04-11

No results posted yet for this study

Summary

Phase 1 study evaluating the safety of combined bilateral globus pallidus internus (GPi) and nucleus basalis of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of Parkinsonism and cognitive dysfunction, respectively, in patients with moderate to advanced Parkinson's disease having mild cognitive impairment.

Conditions

Interventions

DEVICE

Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM.

Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM, at the same trajectory.

DEVICE

GPi stimulation

Bilateral high-frequency neurostimulation of the GPi using a Vercise neurostimulation system

DEVICE

NBM stimulation

Bilateral low-frequency neurostimulation of the NBM using a Vercise neurostimulation system

DEVICE

Sham stimulation

Ineffective neurostimulation by setting 0mA output at the Vercise neurostimulation system

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-20
Primary Completion
2023-08-31
Completion
2024-01-31
FDA Device
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05320523 on ClinicalTrials.gov