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Clinical Trial
. 2012;2(3):215-23.
doi: 10.3233/JPD-2012-012095.

Pilot study assessing the feasibility of applying bilateral subthalamic nucleus deep brain stimulation in very early stage Parkinson's disease: study design and rationale

David Charles  1 , Christopher Tolleson, Thomas L Davis, Chandler E Gill, Anna L Molinari, Mark J Bliton, Michael G Tramontana, Ronald M Salomon, Chris Kao, Lily Wang, Peter Hedera, Fenna T Phibbs, Joseph S Neimat, Peter E Konrad
Affiliations
Clinical Trial

Pilot study assessing the feasibility of applying bilateral subthalamic nucleus deep brain stimulation in very early stage Parkinson's disease: study design and rationale

David Charles et al. J Parkinsons Dis. 2012.

Abstract

Background: Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra.

Objective: We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection.

Methods: We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts.

Results: Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different.

Conclusions: This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease.

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Conflict of interest statement

Conflicts of Interest: Individual author conflict of interest declarations are as follows. Vanderbilt University has received income in excess of $10,000 from grants or con- tracts with Medtronic, Allergan, Ipsen, Merz, UCB, and Teva for research or educational programs led by Dr. Charles. Dr. Charles has received income in excess of $10,000 from Medtronic, Allergan, and Ipsen for education or consulting services. Dr. Davis has received personal compensation and Vanderbilt University has received grants to support research from Medtronic in excess of $10,000. He also served as a consultant for Allergan, Novartis, and UCB and has received payment for lectures from Allergan and Teva as well as payment for development of educa- tional presentations from UCB and Teva. Dr. Hedera has received payment for lectures from Lundbeck. Dr. Phibbs has served as a consultant for Boston Scientific and Medtronic and has received payment for educational presentations for Teva. Dr. Neimat has received personal compensation and Vanderbilt University has received grants to support research from Medtronic in excess of $10,000. Dr. Neimat has also received payment for lectures from Medtronic and FHC, Inc. He has also received reimbursement for travel/accommodations/meeting expenses apart from consultancy. Dr. Konrad has received personal compensation and Vanderbilt University has received grants to support research from Medtronic in excess of $10,000. Dr. Konrad also serves as a consultant for Medtronic and FHC, Inc.

Figures

Figure 1
Figure 1. Inclusion/Exclusion Criteria
Detailed screening measures were employed in order to ensure patient appropriateness for the trial. Subjects not meeting the inclusion/exclusion criteria were not eligible to participate in the trial.
Figure 2
Figure 2. Study Design
This trial was a prospective, randomized, single-blind clinical trial comparing the safety and tolerability of DBS+ODT to ODT alone. Detailed inpatient assessments were performed every 6 months for a total of 2 years to monitor safety.
See this image and copyright information in PMC

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