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Deep Brain Stimulation for Parkinson's Disease Trial

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
deep brain stimulation
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, PD, deep brain stimulation, DBS

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION: Clinical diagnosis of Idiopathic Parkinson's Disease based on the presence of at least 2 of the cardinal motor signs (akinesia/bradykinesia, rigidity, tremor, and gait/balance disorder) and a clear response to levodopa therapy. Hoeh & Yahr staging III or worse "off " medication periods. Intractable, disabling motor fluctuations, dyskinesias, or freezing episodes. Unsatisfactory clinical response to maximal medical management or previous surgical treatment. Stable on Parkinson's medications for at least 30 days with total L-dopa equivalence varying no more than +/- twenty percent during the 30 day period. Absence of cognitive, or psychiatric or other co-morbidities that might interfere with the patient's ability to understand and sign the informed consent form. EXCLUSION: Clinically significant medical history that increases pre- / post operative complications (Cardiac or pulmonary disease, uncontrolled hypertension, diabetes…). Secondary or atypical parkinsonism as suggested by: i. History of stroke, encephalitis, exposure to toxins or neuroleptics. ii. Neurologic signs of upper motor neuron or cerebella involvement, supranuclear gaze palsy, or significant autonomic dysfunction. iii. MRI scan with evidence of significant brain atrophy, lacunar infracts, or iron deposits in the putamen. Dementia as indicated by a Mattis Dementia Rating Scale (DRS) less than 116 or DSM-IV criterion for dementia. Clinically significant psychiatric disorder meeting Structured Clinical Interview for the DSM-IV criteria for an active anxiety, depressive, or psychotic disorder.

Sites / Locations

  • Emory University School of Medicine, Neurology Department
  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

SA #1 Arm 1: Unilateral DBS in GPi

SA #1 Arm 2: Unilateral DBS in STN

SA #2 Arm 1: Bilateral DBS in GPi

SA #2 Arm 2: Bilateral DBS in STN

Arm Description

Patients with GPi bilateral DBS (previously had unilateral DBS in the GPi, now have bilateral DBS in GPi)

Patients with STN bilateral DBS (previously had unilateral DBS in the STN, now have bilateral DBS in STN)

Outcomes

Primary Outcome Measures

Mean change in total UPDRS score (baseline to six-months post DBS surgery)
The Unified Parkinson's Disease Rating Scale (UPDRS) is a commonly used survey tool used to assess symptom severity of patients with Parkinson's disease (PD). It covers several different domains including 1) thought, behavior and mood 2) activities of daily living 3) motor activity 4) complications of therapy and others. The mean change from baseline to six months after DBS surgery for patients with DBS in the GPi vs the STN will be compared after being adjusted for differences in age and time since PD diagnosis.

Secondary Outcome Measures

Mean change in UPDRS subscales and individual scores
Subscales include domains including behavior and mood, activities of daily living, motor function, complications of therapy and others. Individual scores to be evaluated include scores for tremor, rigidity, bradykensia, gait, and postural stability. Other secondary endpoints include: Hoehn and Yahr staging, Modified Schwab and England Scale, timed test results, scores from psychiatric and quality of life assessments.

Full Information

First Posted
February 4, 2003
Last Updated
April 2, 2015
Sponsor
University of Minnesota
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00053625
Brief Title
Deep Brain Stimulation for Parkinson's Disease Trial
Official Title
Deep Brain Stimulation for Parkinson's Disease Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) and the subthalamic nucleus (STN) on motor, neuropsychological and psychiatric function, and quality of life in patients with Parkinson's disease.
Detailed Description
Medical therapy is the mainstay of treatment for patients with Parkinson's disease (PD). After several years of drug therapy, however, a large proportion of patients experience worsening of their parkinsonism and develop incapacitating motor fluctuations and dyskinesias. To deal with this, attention has been directed to surgical procedures, such as deep brain stimulation (DBS). Recently, stimulating the areas of the brain that control movement, the globus pallidus (Gpi) and subthalamic nucleus (STN), has been proposed as a therapy for treating many of the disabling symptoms associated with PD and drug-induced side effects. The major aim of this 5-year study is to carry out a prospective, double blinded, randomized, clinical trial of DBS for medically intractable PD. The study will evaluate the effect of DBS in the Gpi and STN on motor, neuropsychological and psychiatric function, and quality of life in patients with PD. The study also will address two key issues: 1) whether there are differences between unilateral Gpi-DBS and STN-DBS and 2) which patients are the best candidates for bilateral DBS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, PD, deep brain stimulation, DBS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SA #1 Arm 1: Unilateral DBS in GPi
Arm Type
Active Comparator
Arm Title
SA #1 Arm 2: Unilateral DBS in STN
Arm Type
Active Comparator
Arm Title
SA #2 Arm 1: Bilateral DBS in GPi
Arm Type
Active Comparator
Arm Description
Patients with GPi bilateral DBS (previously had unilateral DBS in the GPi, now have bilateral DBS in GPi)
Arm Title
SA #2 Arm 2: Bilateral DBS in STN
Arm Type
Active Comparator
Arm Description
Patients with STN bilateral DBS (previously had unilateral DBS in the STN, now have bilateral DBS in STN)
Intervention Type
Procedure
Intervention Name(s)
deep brain stimulation
Other Intervention Name(s)
DBS
Intervention Description
Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood.
Primary Outcome Measure Information:
Title
Mean change in total UPDRS score (baseline to six-months post DBS surgery)
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) is a commonly used survey tool used to assess symptom severity of patients with Parkinson's disease (PD). It covers several different domains including 1) thought, behavior and mood 2) activities of daily living 3) motor activity 4) complications of therapy and others. The mean change from baseline to six months after DBS surgery for patients with DBS in the GPi vs the STN will be compared after being adjusted for differences in age and time since PD diagnosis.
Time Frame
Followed for minimum of 5 years
Secondary Outcome Measure Information:
Title
Mean change in UPDRS subscales and individual scores
Description
Subscales include domains including behavior and mood, activities of daily living, motor function, complications of therapy and others. Individual scores to be evaluated include scores for tremor, rigidity, bradykensia, gait, and postural stability. Other secondary endpoints include: Hoehn and Yahr staging, Modified Schwab and England Scale, timed test results, scores from psychiatric and quality of life assessments.
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION: Clinical diagnosis of Idiopathic Parkinson's Disease based on the presence of at least 2 of the cardinal motor signs (akinesia/bradykinesia, rigidity, tremor, and gait/balance disorder) and a clear response to levodopa therapy. Hoeh & Yahr staging III or worse "off " medication periods. Intractable, disabling motor fluctuations, dyskinesias, or freezing episodes. Unsatisfactory clinical response to maximal medical management or previous surgical treatment. Stable on Parkinson's medications for at least 30 days with total L-dopa equivalence varying no more than +/- twenty percent during the 30 day period. Absence of cognitive, or psychiatric or other co-morbidities that might interfere with the patient's ability to understand and sign the informed consent form. EXCLUSION: Clinically significant medical history that increases pre- / post operative complications (Cardiac or pulmonary disease, uncontrolled hypertension, diabetes…). Secondary or atypical parkinsonism as suggested by: i. History of stroke, encephalitis, exposure to toxins or neuroleptics. ii. Neurologic signs of upper motor neuron or cerebella involvement, supranuclear gaze palsy, or significant autonomic dysfunction. iii. MRI scan with evidence of significant brain atrophy, lacunar infracts, or iron deposits in the putamen. Dementia as indicated by a Mattis Dementia Rating Scale (DRS) less than 116 or DSM-IV criterion for dementia. Clinically significant psychiatric disorder meeting Structured Clinical Interview for the DSM-IV criteria for an active anxiety, depressive, or psychotic disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerrold L Vitek, M.D., Ph.D.
Organizational Affiliation
Cleveland Clinic Foundation, Director - Functional Neuroscience Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahlon R. DeLong, M.D.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine, Neurology Department
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Deep Brain Stimulation for Parkinson's Disease Trial

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