Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease
Primary Purpose
Cognitive Deficit
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NBM-DBS
DBS
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Deficit
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NBM-DBS on
DBS off
Arm Description
DBS is programmed to stimulate the NbM
DBS is turned off, no stimulation will be exerted
Outcomes
Primary Outcome Measures
Changes in global cognitive function measured by the Scales for Outcomes in Parkinson's disease-Cognition (SCOPA-COG)
Secondary Outcome Measures
Changes of Unified Parkinson's Disease Rating Scale (UPDRS) part 3
Changes of the power of background EEG frequencies
Score changes of stroop test
Score changes of the Trail Making test
Score changes of the digit span test of Wechsler Adult Intelligence Scale III
Score changes of the symbol digit modality test (SDMT)
Score changes of the Hospital Anxiety and Depression Scale
Score changes of the Apathy Evaluation Scale
Full Information
NCT ID
NCT02763397
First Posted
April 27, 2016
Last Updated
May 4, 2016
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT02763397
Brief Title
Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease
Official Title
Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Deficit
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NBM-DBS on
Arm Type
Experimental
Arm Description
DBS is programmed to stimulate the NbM
Arm Title
DBS off
Arm Type
Placebo Comparator
Arm Description
DBS is turned off, no stimulation will be exerted
Intervention Type
Device
Intervention Name(s)
NBM-DBS
Intervention Description
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
Intervention Name(s)
DBS
Intervention Description
DBS will be switched off
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Changes of Unified Parkinson's Disease Rating Scale (UPDRS) part 3
Time Frame
3 days of the screening phase
Title
Changes of the power of background EEG frequencies
Time Frame
2 weeks of the crossover trial phase
Title
Score changes of stroop test
Time Frame
2 weeks of the crossover trial phase
Title
Score changes of the Trail Making test
Time Frame
2 weeks of the crossover trial phase
Title
Score changes of the digit span test of Wechsler Adult Intelligence Scale III
Time Frame
2 weeks of the crossover trial phase
Title
Score changes of the symbol digit modality test (SDMT)
Time Frame
2 weeks of the crossover trial phase
Title
Score changes of the Hospital Anxiety and Depression Scale
Time Frame
2 weeks of the crossover trial phase
Title
Score changes of the Apathy Evaluation Scale
Time Frame
2 weeks of the crossover trial phase
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Nazmuddin, MD
Email
m.nazmuddin@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teus van Laar, Prof. Dr.
Organizational Affiliation
Department of Neurology, University Medical Center Groningen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease
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