Status:
COMPLETED
Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Parkinson's Disease
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
Bilateral subthalamic nucleus deep brain stimulation (B-STN DBS) is one of the most effective surgical treatments for PD patients suffering from levodopa-induced motor complications. The relatively lo...
Detailed Description
This pilot trial is designed specifically to collect the preliminary safety and tolerability data necessary to conduct a future phase III clinical trial to investigate the hypothesis that deep brain s...
Eligibility Criteria
Inclusion
- Patients must have a clinical diagnosis of probable idiopathic PD.
- Demonstrated response to dopaminergic therapy, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based upon the UPDRS motor examination subscore, following the administration of their dopamine agonist (DA) drug(s) during the screening neurological examination.
- Hoehn and Yahr (H\&Y) stage II when OFF medication.
- No contraindications to surgery.
- Age between 50 and 75 years old.
- Available for follow-up for four years.
- 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.
- Levodopa or dopamine agonist therapy for greater than six months but less than or equal to four years.
Exclusion
- 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 implantable cardioverter defibrillators (ICD's).
- Patients who have medical conditions that require repeat MRI scans or diathermy treatments.
- Evidence of existing dyskinesias or motor fluctuations.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00282152
Start Date
March 1 2006
End Date
October 1 2015
Last Update
May 30 2017
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