Feasibility Study to Evaluate Deep Brain Stimulation (DBS) Settings for the Treatment of Parkinson's Disease

Withdrawn before enrolling · Not applicable

Conditions studied: Parkinson's Disease

In brief

The purpose of this study is to assess the cognitive performance in patients with advanced Parkinson's disease receiving Deep Brain Stimulation (DBS) with settings predetermined clinically to settings derived from a patient-specific computational model.

Key facts

Study ID

NCT01230151

Run by

Intelect Medical, Inc.

People needed

80

Starts

2010-12-01

Last updated by the study team

2011-02-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is able and willing to provide informed consent to participate in the study.
• The patient's implanted DBS system shall be the Medtronic, Inc. Activa® System. The Medtronic Activa System may consists of either, Soletra®, Kinetra® Activa® RC, or Activa® PC Neurostimulator(s) and two DBS Leads (Model 3387 or 3389).
• Patient shall have bilateral DBS of the subthalamic nucleolus (STN).
• Patient shall have stable DBS stimulation without changes in stimulation parameters for no less than 3 months prior to enrollment.
• Patient shall have stable and optimal regimen of antiparkinson drug therapy for no less than 3 months prior to enrollment.
• Patient, and caregiver if applicable, is able and willing to be available for study visits throughout the duration of the study (e.g. no planned relocation of residence or extended vacation during the study that would prevent compliance with study visit schedule).
• Availability, from the patient's medical records, of a Pre-op MRI and high resolution CT with artifact reduction no less than six (6) weeks post-op.
• Patient shall have Hoehn and Yahr stage III or worse when off stimulation and off medication.
• Patient shall have demonstrated good response to L-DOPA, defined as no less than a 30% improvement in a UPDRS-III motor exam following the administration of L-DOPA during their screening neurological exam.
• Patient shall have demonstrated good response to DBS following the administration of DBS while off medication, defined as an improvement in UPDRS-III motor scores better than their improvement to L-DOPA (as determine in above) or no less than 20% worse of an improvement.

You may not qualify if…

• Evidence of secondary or atypical Parkinsonism as suggested by: stroke, encephalitis, exposure to toxins, neuroleptic antipsychotics, neurologic signs of upper motor neuron or cerebellar involvement, or supranuclear palsy.
• Dementia as evidenced by a mini-mental state examination of 24 or below (MMSE ≥ 24).
• Prior participation in the Intelect Medical GUIDE study.

Where it is running

• University of Florida — Gainesville, Florida, United States
• North Shore University Hospital — Manhasset, New York, United States
• Evergreen Healthcare — Kirkland, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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