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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
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Deficit

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 27, 2016
    Last Updated
    May 4, 2016
    Sponsor
    University Medical Center Groningen
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    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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