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Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Charles, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00282152
First received: January 23, 2006
Last updated: January 25, 2016
Last verified: January 2016
History of Changes
  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
Parkinson's Disease
 Device: B-STN DBS
Drug: Optimal drug therapy

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Safety: Time to reach a 4 point increase (worsening) in UPDRS Motor score [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
Enrollment: 30
Study Start Date: March 2006
Study Completion Date: October 2015
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ODT
Patients receive optimal drug therapy as prescribed by their treating neurologist.
 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. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
Experimental: DBS+ODT
Subjects receive B-STN DBS and continue to take optimal drug therapy as prescribed 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. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 25, 2016
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 September 23, 2016