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Withdrawn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
About this trial
This is an interventional treatment trial for Parkinson's Disease
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.
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
NCT ID
NCT02541617
First Posted
April 22, 2015
Last Updated
April 26, 2017
Sponsor
Vanderbilt University
Collaborators
Medtronic
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
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Hub and Spoke, Comparative Outcomes for Parkinson's Disease Treated With Deep Brain Stimulation
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