Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD) - Full Text View

Sponsor:	Vanderbilt University
Information provided by (Responsible Party):	David Charles, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00282152

Purpose

B-STN DBS is one of the most effective surgical treatments for PD patients suffering from levodopa-induced motor complications. The relatively low incidence of permanent adverse effects and the potential for neuroprotection and alteration of the natural course of PD suggest a highly favorable benefit-to-risk ratio of this procedure. Since neuroprotection is best applied early in the disease course when there are more surviving neurons, we believe that further investigation of this procedure is warranted. The proposed pilot study will provide the necessary data to substantiate the safety and tolerability of the procedure as well as provide data for the design of a full-scale, multicenter trial to investigate the hypothesis that B-STN DBS is a safe and effective treatment to slow the progression of PD.

Condition	Intervention	Phase
Parkinson's Disease	Device: B-STN DBS Drug: Optimal drug therapy	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Safety and Tolerability of Neurostimulation in Early Stage Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Safety: Time to reach a 20% increase (worsening) in UPDRS Motor score [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
Efficacy: Reduction in medication after DBS therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2006
Estimated Study Completion Date:	August 2014
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: ODT Subjects receive optimal drug therapy - Standard FDA-approved PD medications.	Drug: Optimal drug therapy The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.
Experimental: DBS+ODT Subjects receive B-STN DBS and continue to take standard anti-PD medications as recommended by their treating neurologist.	Device: B-STN DBS Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed. Drug: Optimal drug therapy The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.

Arms

Assigned Interventions

Active Comparator: ODT

Subjects receive optimal drug therapy - Standard FDA-approved PD medications.

Drug: Optimal drug therapy

The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.

Experimental: DBS+ODT

Subjects receive B-STN DBS and continue to take standard anti-PD medications as recommended by their treating neurologist.

Device: B-STN DBS

Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.

Drug: Optimal drug therapy

The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.

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 stimulation of the subthalamic nucleus in subjects with early Parkinson's will slow the progression of the disease.

The study design is a prospective, randomized, blinded, single-center trial comparing the safety and tolerability of B-STN DBS + ODT vs. ODT alone (control, standard of care) in 30 subjects (15 per group) with early PD (Hoehn and Yahr stage II when off medication).

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 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 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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282152

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

P. David Charles, MD

Vanderbilt University Department of Neurology

More Information

No publications provided

Responsible Party:	David Charles, Associate Professor of Neurology, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00282152 History of Changes
Other Study ID Numbers:	040797, 1363, G050016
Study First Received:	January 23, 2006
Last Updated:	January 19, 2012
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Early Stage Parkinson's Disease
Parkinson's Disease
Deep Brain Stimulation
PD
DBS

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on February 12, 2012