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| Sponsored by: |
Vanderbilt University |
|---|---|
| Information provided by: | 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: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Safety and Tolerability of Neurostimulation in Early Stage Parkinson's Disease |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
ODT: Active Comparator
Subjects receive optimal drug therapy - Standard FDA-approved PD medications.
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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.
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DBS+ODT: Experimental
Subjects receive B-STN DBS and continue to take standard anti-PD medications as recommended by their treating neurologist.
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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.
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.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | P. David Charles, MD | Vanderbilt University Department of Neurology |
More Information
| Responsible Party: | Vanderbilt University ( David Charles ) |
| Study ID Numbers: | 040797, 1363, G050016 |
| Study First Received: | January 23, 2006 |
| Last Updated: | June 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00282152 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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Early Stage Parkinson's Disease Parkinson's Disease Deep Brain Stimulation PD DBS |
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Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
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Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |