Activa Parkinson’s Control Therapy — Study Design

Study Design
Eighteen centers participated in the Activa Parkinson’s Control Therapy multicenter clinical studies¹: 11 in Europe, four in the United States, two in Australia and one in Canada.

A total of 160 patients received deep brain stimulators implanted bilaterally in the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Under certain circumstances, the second device/system was not implanted.

The study population included male and female patients, ages 30 to 75, who were diagnosed with idiopathic Parkinson’s disease as determined by the clinical presence of three of the four (or two of three, as stated in the European protocol) cardinal features—tremor, rigidity, bradykinesia, postural instability—and who showed good levodopa response.

Patients were to have a disability level due to Parkinson’s disease based on the following criteria:

• Hoehn and Yahr stage 3 or worse when in the “off” state;
• Unified Parkinson’s Disease Rating Scale (UPDRS) motor exam score of 30 or more in the “off” state; and
• Complications of levodopa therapy motor responses including motor fluctuations and dyskinesias.

Patients participated in the studies for 12 months, with two pre-implant visits and follow-up visits at 1, 3, 6, and 12 months. Each patient’s dosage of antiparkinsonian medication was held constant for one month prior to surgery. Following surgery, physicians monitored antiparkinsonian medication status throughout the remainder of the study.

References

1. Medtronic Activa Therapy Clinical Summary 2002, UC19990178 EN.

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