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Combined Subthalamic and Nucleus Basalis Meynert Deep Brain Stimulation for Parkinson's Disease With Dementia

NCT02589925 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-05-22

No results posted yet for this study

Summary

Phase 1 study evaluating the safety of combined bilateral subthalamic nucleus (STN) and basal nucleus of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of Parkinsonism and cognitive dysfunction in patients with advanced Parkinson's disease having mild to moderate dementia.

Conditions

Interventions

DEVICE

Vercise deep brain stimulation

implantation of a Vercise neurostimulation system

PROCEDURE

subthalamic nucleus (STN) stimulation

bilateral high-frequency neurostimulation of the subthalamic nucleus using a Vercise neurostimulation system

PROCEDURE

NBM stimulation

bilateral low-frequency neurostimulation of the subthalamic nucleus using a Vercise neurostimulation system

PROCEDURE

sham stimulation

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

Sponsors & Collaborators

  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Jens Volkmann, MD, PhD · Wuerzburg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • Germany

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 NCT02589925 on ClinicalTrials.gov