Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease

NCT ID: NCT02763397

Last Updated: 2016-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Brief Summary

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The existing DBS setting in patients with DBS of the globus pallidus interna (GPi), which aims to treat motor symptoms by a high-frequency stimulation, will be temporarily reprogramed to stimulate the NbM at a low frequency using the distal electrodes positioned in the vicinity of the NBM.

This study aims to investigate the neuropsychological effect of low frequency stimulation of the nucleus basalis of Meynert (NBM) in advanced Parkinson's disease (PD) patients, who were previously treated with deep brain stimulation (DBS) of the globus pallidus interna (GPi).

Detailed Description

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The existing DBS setting in patients with GPi DBS, which aims to treat motor symptoms by a high-frequency stimulation, will be temporarily reprogramed to stimulate the NBM at a low frequency using the distal electrodes positioned in the vicinity of the NBM.This study consists of a three-day screening study of the NbM stimulation followed by a two-week, randomized, single-blind, crossover trial. Between the screening study and the crossover trial, one week of washout period will be applied to eliminate potential carryover effect from the previous stimulation.

This study aims to investigate the neuropsychological effect of low frequency stimulation of the nucleus basalis of Meynert (NBM) in advanced Parkinson's disease (PD) patients, who were previously treated with deep brain stimulation (DBS) of the globus pallidus interna (GPi).

Conditions

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Cognitive Deficit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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NBM-DBS on

DBS is programmed to stimulate the NbM

Group Type EXPERIMENTAL

NBM-DBS

Intervention Type DEVICE

DBS which has already been implanted aiming initially to stimulate the GPi will be reprogrammed in order to stimulate more distal structure, the NBM.

DBS off

DBS is turned off, no stimulation will be exerted

Group Type PLACEBO_COMPARATOR

DBS

Intervention Type DEVICE

DBS will be switched off

Interventions

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NBM-DBS

DBS which has already been implanted aiming initially to stimulate the GPi will be reprogrammed in order to stimulate more distal structure, the NBM.

Intervention Type DEVICE

DBS

DBS will be switched off

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with GPi stimulation, with the NBM within the vicinity of the electric field of at least one DBS electrode.
* Patients should be able to give informed consent
* Patients should be on a stable medication regimen for at least 4 weeks

Exclusion Criteria

* any unstable internal disease
* Subject with significant worsening of motor function during the pilot screening study, which is indicated by an increase of the UPDRS part III score more than 30%, will not continue to the crossover trial
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Teus van Laar

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Teus van Laar, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University Medical Center Groningen

Central Contacts

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Muhammad Nazmuddin, MD

Role: CONTACT

Other Identifiers

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NL 57011.042.16

Identifier Type: -

Identifier Source: org_study_id

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