Deep Brain Stimulation for Parkinson's Disease Trial
1 other identifier
interventional
123
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 1999
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedFirst Submitted
Initial submission to the registry
February 4, 2003
CompletedFirst Posted
Study publicly available on registry
February 5, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedApril 3, 2015
April 1, 2015
9.5 years
February 4, 2003
April 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Followed for minimum of 5 years
Secondary Outcomes (1)
Mean change in UPDRS subscales and individual scores
Baseline to 6 months
Study Arms (4)
SA #1 Arm 1: Unilateral DBS in GPi
ACTIVE COMPARATORSA #1 Arm 2: Unilateral DBS in STN
ACTIVE COMPARATORSA #2 Arm 1: Bilateral DBS in GPi
ACTIVE COMPARATORPatients with GPi bilateral DBS (previously had unilateral DBS in the GPi, now have bilateral DBS in GPi)
SA #2 Arm 2: Bilateral DBS in STN
ACTIVE COMPARATORPatients with STN bilateral DBS (previously had unilateral DBS in the STN, now have bilateral DBS in STN)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Emory University School of Medicine, Neurology Department
Atlanta, Georgia, 30322, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerrold L Vitek, M.D., Ph.D.
Cleveland Clinic Foundation, Director - Functional Neuroscience Research Center
- PRINCIPAL INVESTIGATOR
Mahlon R. DeLong, M.D.
Emory University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2003
First Posted
February 5, 2003
Study Start
June 1, 1999
Primary Completion
December 1, 2008
Study Completion
June 1, 2009
Last Updated
April 3, 2015
Record last verified: 2015-04