- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00282152
Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)
Safety and Tolerability of Neurostimulation in Early Stage Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 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. |
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to 24 months
|
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
|
baseline to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in UPDRS Part I, Mentation Behavior and Mood
Time Frame: baseline to 24 months
|
Score: 0-16 0 =normal, 16 = most disability
|
baseline to 24 months
|
Change in UPDRS Part II, Activities of Daily Living
Time Frame: baseline to 24 months
|
Score: 0-52 0 =normal, 52 = most limited
|
baseline to 24 months
|
Change in UPDRS Part III, Motor Examination, Excluding Rigidity
Time Frame: baseline to 24 months
|
Score: 0-56 0 = full movement, 56 = most limited
|
baseline to 24 months
|
Change in UPDRS Part IV, Complications of Therapy
Time Frame: baseline to 24 months
|
Score: 0-23 0 =no complications, 23 = most complications
|
baseline to 24 months
|
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 |
baseline to 24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: P. David Charles, MD, Vanderbilt University Department of Neurology
Publications and helpful links
General Publications
- Hacker ML, Turchan M, Heusinkveld LE, Currie AD, Millan SH, Molinari AL, Konrad PE, Davis TL, Phibbs FT, Hedera P, Cannard KR, Wang L, Charles D. Deep brain stimulation in early-stage Parkinson disease: Five-year outcomes. Neurology. 2020 Jul 28;95(4):e393-e401. doi: 10.1212/WNL.0000000000009946. Epub 2020 Jun 29.
- Millan SH, Hacker ML, Turchan M, Molinari AL, Currie AD, Charles D. Subthalamic Nucleus Deep Brain Stimulation in Early Stage Parkinson's Disease Is Not Associated with Increased Body Mass Index. Parkinsons Dis. 2017;2017:7163801. doi: 10.1155/2017/7163801. Epub 2017 Jun 6.
- Charles PD, Dolhun RM, Gill CE, Davis TL, Bliton MJ, Tramontana MG, Salomon RM, Wang L, Hedera P, Phibbs FT, Neimat JS, Konrad PE. Deep brain stimulation in early Parkinson's disease: enrollment experience from a pilot trial. Parkinsonism Relat Disord. 2012 Mar;18(3):268-73. doi: 10.1016/j.parkreldis.2011.11.001. Epub 2011 Nov 21.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 040797
- 1363 (Clinical Research Center)
- G050016 (FDA IDE)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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