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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00282152
Recruitment Status : Completed
First Posted : January 25, 2006
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
David Charles, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE January 23, 2006
First Posted Date  ICMJE January 25, 2006
Results First Submitted Date  ICMJE April 19, 2017
Results First Posted Date  ICMJE May 30, 2017
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE March 2006
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • Safety: Time to Reach a 4 Point Increase (Worsening) in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score [ Time Frame: baseline to 24 months ]
    The primary hypothesis of this feasibility trial was focused on safety and tolerability and that the DBS+ODT group would not worsen more quickly than the ODT group.
  • Levodopa Equivalents, Change From Baseline [ Time Frame: baseline to 24 months ]
    100 mg of levodopa with a dopa-decarboxylase inhibitor = 133 mg of controlled-release levodopa preparations = total levodopa dose + (total levodopa dose x 0.33) of levodopa with dopa-decarboxylase and entacapone = 1 mg of pergolide, pramipexole, or lisuride = 5 mg of ropinirole = 3.3 mg of rotigotine
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2006)
  • Safety: Time to reach a 20% increase (worsening) in UPDRS Motor score
  • Efficacy: Reduction in medication after DBS therapy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • Change in UPDRS Part I, Mentation Behavior and Mood [ Time Frame: baseline to 24 months ]
    Score: 0-16 0 =normal, 16 = most disability
  • Change in UPDRS Part II, Activities of Daily Living [ Time Frame: baseline to 24 months ]
    Score: 0-52 0 =normal, 52 = most limited
  • Change in UPDRS Part III, Motor Examination, Excluding Rigidity [ Time Frame: baseline to 24 months ]
    Score: 0-56 0 = full movement, 56 = most limited
  • Change in UPDRS Part IV, Complications of Therapy [ Time Frame: baseline to 24 months ]
    Score: 0-23 0 =no complications, 23 = most complications
  • Change in Total UPDRS [ Time Frame: baseline to 24 months ]
    The Total Unified Parkinson's Disease Rating Scale (UPDRS) is a composite scale, consisting of four sections that evaluate mood and behavior, activities of daily living, motor symptoms, and complications of medical therapy. Range is 0 to 16, with 16 being maximal disability
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)
Official Title  ICMJE Safety and Tolerability of Neurostimulation in Early Stage Parkinson's Disease
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 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.
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 + Optimal Drug Therapy (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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • 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. In mid- and advanced stage Parkinson's disease, 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.
Study Arms  ICMJE
  • Active Comparator: ODT
    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.
    Intervention: Drug: Optimal drug therapy
  • Experimental: DBS+ODT

    Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.

    B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, 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.

    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.

    Interventions:
    • Device: B-STN DBS
    • Drug: Optimal drug therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2017)
37
Original Enrollment  ICMJE
 (submitted: January 23, 2006)
30
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00282152
Other Study ID Numbers  ICMJE 040797
1363 ( Other Identifier: Clinical Research Center )
G050016 ( Other Identifier: FDA IDE )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Charles, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: P. David Charles, MD Vanderbilt University Department of Neurology
PRS Account Vanderbilt University Medical Center
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP