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Hub and Spoke, Comparative Outcomes for Parkinson's Disease Treated With Deep Brain Stimulation (Hub&Spoke)

Primary Purpose

Parkinson's Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Programming by community Neurologist
Standard of care
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients must have a clinical diagnosis of probable idiopathic PD. The diagnosis will be based upon the presence of at least three of four clinical features according to diagnostic utility (Resting Tremor, Bradykinesia, Rigidity, Asymmetric Onset) and an absence of clinical features suggestive of an alternative diagnosis.
  2. Demonstrated response to dopaminergic therapy. In order to exclude patients with a possible alternative diagnosis, all subjects included in the study must have demonstrated a good response to DA drugs, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based upon the UPDRS motor examination subscore, following the administration of their DA drug(s) during the screening neurological examination.
  3. Advanced Parkinson's disease.
  4. No contraindications to surgery.
  5. Age between 50 and 75 years old.
  6. Available for follow-up for the entire duration of the study.
  7. Informed Consent: The subject understands the risks, benefits, and alternatives to the study procedures and participation in the study.
  8. MRI within normal range for age

Exclusion Criteria:

  1. Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by features unusual early in the clinical course: Prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset; dementia preceding motor symptoms; supranuclear gaze palsy (other than restriction of upward gaze) or slowing of vertical saccades in the first year; severe, symptomatic dysautonomia unrelated to medications; documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (such as suitably located focal brain lesions or neuroleptic use within the past 6 months)
  2. Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
  3. Evidence of dementia
  4. Major psychiatric disorder
  5. Previous brain operation or injury.
  6. Active participation in another clinical trial for the treatment of PD.
  7. Patients who have demand cardiac pacemakers or who have medical conditions that require repeat MRI scans.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Movement Disorder Center

    Programming by community Neurologist

    Arm Description

    Device programming, Deep Brain stimulator will be programmed at the implanting center, standard of care

    Device programming, Deep Brain Stimulator will be programmed by community Neurologist

    Outcomes

    Primary Outcome Measures

    UPDRS part IV
    Change in score from baseline, complication of medical therapy for Parkinson's disease

    Secondary Outcome Measures

    UPDRS
    Change from baseline, composite score of all 4 parts of the UPDRS
    PDQ-39
    Change from baseline in quality of life
    Obeso Dyskinesia Rating Scale
    Change from baseline, involuntary movements caused by Parkinson's disease treatment
    Hoehn and Yahr rating
    Change from baseline, in stage of disease
    Schwab and England ADL score
    Change from baseline, signs and symptoms of depression
    Parkinson's medication in LEDD
    Change from baseline in total Parkinson's disease medications
    DBS voltage/current
    One year settings of DBS system
    DBS electrode configuration
    One year settings of DBS system
    DBS pulse width
    One year settings of DBS system
    DBS frequency
    One year settings of DBS system

    Full Information

    First Posted
    April 22, 2015
    Last Updated
    April 26, 2017
    Sponsor
    Vanderbilt University
    Collaborators
    Medtronic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02541617
    Brief Title
    Hub and Spoke, Comparative Outcomes for Parkinson's Disease Treated With Deep Brain Stimulation
    Acronym
    Hub&Spoke
    Official Title
    Hub and Spoke, Comparative Outcomes for Parkinson's Disease Treated With Deep Brain Stimulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of enrollment
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    February 2017 (Anticipated)
    Study Completion Date
    February 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University
    Collaborators
    Medtronic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Outcomes study to test the hypothesis that patients first identified by community-based neurologists, implanted by a networked movement disorders center, and then managed by the same community-based neurologist will have clinical outcomes comparable to movement disorders centers.
    Detailed Description
    The proposed outcomes study is a prospective, randomized, multicenter, single blind, non-inferiority clinical trial comparing the safety and efficacy of deep brain stimulation therapy applied in a community-based model for 62 subjects with Parkinson's disease appropriate for STN DBS therapy. Eight community-based private neurology practices will be networked to Vanderbilt University Medical Center (VUMC). Neurologists for each practice will attend structured educational programs offered by Medtronic in the identification, selection, and management of Parkinson's disease patients with DBS therapy. Following this educational program, each practice will identify subjects for implantation VUMC. Following screening and baseline visits at VUMC, appropriate patients will be implanted with bilateral subthalamic nucleus deep brain stimulating therapy. The initial post-operative programming will be done at VUMC four weeks after implantation. 8 subjects will then be equally randomized with half being followed for long-term management by the community-based neurologist. The other half will be followed at VUMC. All subsequent outpatient evaluation management of medications and deep brain stimulation will be managed per standard of care at the location assigned by randomization, community-based private neurology practice or VUMC. All subjects will be enrolled during the first 24 months of the study. Follow-up evaluations at 12 months will be performed at VUMC. Each patient identified by the community-based neurologist for implantation will be assessed at VUMC. This assessment will include a videotaped off and on UPDRS III rating, neuropsychological testing, and appropriateness as outlined in the patient selection educational program. Patients will be implanted by bilateral subthalamic nucleus deep brain stimulation therapy within 120 days of their initial assessment. The initial post-operative programming will be performed four weeks post-operatively, this is all standard of care. Subjects will then be randomized to be either managed by their community-based neurologist or at VUMC. Follow-up evaluations at 12 months will include a videotaped on and off UPDRS rating and neuropsychological testing, anti-parkinson medication dosages, and quality of life measures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Movement Disorder Center
    Arm Type
    Active Comparator
    Arm Description
    Device programming, Deep Brain stimulator will be programmed at the implanting center, standard of care
    Arm Title
    Programming by community Neurologist
    Arm Type
    Experimental
    Arm Description
    Device programming, Deep Brain Stimulator will be programmed by community Neurologist
    Intervention Type
    Procedure
    Intervention Name(s)
    Programming by community Neurologist
    Intervention Description
    Deep Brain stimulator with be programmed by a community Neurologist
    Intervention Type
    Procedure
    Intervention Name(s)
    Standard of care
    Intervention Description
    Deep Brain Stimulator will be programmed with at the implanting movement disorders center
    Primary Outcome Measure Information:
    Title
    UPDRS part IV
    Description
    Change in score from baseline, complication of medical therapy for Parkinson's disease
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    UPDRS
    Description
    Change from baseline, composite score of all 4 parts of the UPDRS
    Time Frame
    One Year
    Title
    PDQ-39
    Description
    Change from baseline in quality of life
    Time Frame
    One year
    Title
    Obeso Dyskinesia Rating Scale
    Description
    Change from baseline, involuntary movements caused by Parkinson's disease treatment
    Time Frame
    One year
    Title
    Hoehn and Yahr rating
    Description
    Change from baseline, in stage of disease
    Time Frame
    One year
    Title
    Schwab and England ADL score
    Description
    Change from baseline, signs and symptoms of depression
    Time Frame
    One year
    Title
    Parkinson's medication in LEDD
    Description
    Change from baseline in total Parkinson's disease medications
    Time Frame
    One year
    Title
    DBS voltage/current
    Description
    One year settings of DBS system
    Time Frame
    One year
    Title
    DBS electrode configuration
    Description
    One year settings of DBS system
    Time Frame
    One year
    Title
    DBS pulse width
    Description
    One year settings of DBS system
    Time Frame
    one year
    Title
    DBS frequency
    Description
    One year settings of DBS system
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients must have a clinical diagnosis of probable idiopathic PD. The diagnosis will be based upon the presence of at least three of four clinical features according to diagnostic utility (Resting Tremor, Bradykinesia, Rigidity, Asymmetric Onset) and an absence of clinical features suggestive of an alternative diagnosis. Demonstrated response to dopaminergic therapy. In order to exclude patients with a possible alternative diagnosis, all subjects included in the study must have demonstrated a good response to DA drugs, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based upon the UPDRS motor examination subscore, following the administration of their DA drug(s) during the screening neurological examination. Advanced Parkinson's disease. No contraindications to surgery. Age between 50 and 75 years old. Available for follow-up for the entire duration of the study. Informed Consent: The subject understands the risks, benefits, and alternatives to the study procedures and participation in the study. MRI within normal range for age Exclusion Criteria: Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by features unusual early in the clinical course: Prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset; dementia preceding motor symptoms; supranuclear gaze palsy (other than restriction of upward gaze) or slowing of vertical saccades in the first year; severe, symptomatic dysautonomia unrelated to medications; documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (such as suitably located focal brain lesions or neuroleptic use within the past 6 months) Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension). Evidence of dementia Major psychiatric disorder Previous brain operation or injury. Active participation in another clinical trial for the treatment of PD. Patients who have demand cardiac pacemakers or who have medical conditions that require repeat MRI scans.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fenna T Phibbs, MD
    Organizational Affiliation
    Vanderbilt Univeristy Medical center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Hub and Spoke, Comparative Outcomes for Parkinson's Disease Treated With Deep Brain Stimulation

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