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

May 4, 2016 updated by: Teus van Laar, University Medical Center Groningen

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Anticipated)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NBM-DBS on
DBS is programmed to stimulate the NbM
Device: 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.
Placebo Comparator: DBS off
DBS is turned off, no stimulation will be exerted
Device: DBS
DBS will be switched off

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in global cognitive function measured by the Scales for Outcomes in Parkinson's disease-Cognition (SCOPA-COG)
Time Frame: 2 weeks of the crossover trial phase
2 weeks of the crossover trial phase

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of Unified Parkinson's Disease Rating Scale (UPDRS) part 3
Time Frame: 3 days of the screening phase
3 days of the screening phase
Changes of the power of background EEG frequencies
Time Frame: 2 weeks of the crossover trial phase
2 weeks of the crossover trial phase
Score changes of stroop test
Time Frame: 2 weeks of the crossover trial phase
2 weeks of the crossover trial phase
Score changes of the Trail Making test
Time Frame: 2 weeks of the crossover trial phase
2 weeks of the crossover trial phase
Score changes of the digit span test of Wechsler Adult Intelligence Scale III
Time Frame: 2 weeks of the crossover trial phase
2 weeks of the crossover trial phase
Score changes of the symbol digit modality test (SDMT)
Time Frame: 2 weeks of the crossover trial phase
2 weeks of the crossover trial phase
Score changes of the Hospital Anxiety and Depression Scale
Time Frame: 2 weeks of the crossover trial phase
2 weeks of the crossover trial phase
Score changes of the Apathy Evaluation Scale
Time Frame: 2 weeks of the crossover trial phase
2 weeks of the crossover trial phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Teus van Laar, Prof. Dr., Department of Neurology, University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL 57011.042.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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