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

Intelect Medical

Status

Withdrawn

Conditions

Parkinson's Disease

Treatments

Device: GUIDE software, Version 0.1

Device: Clinically defined stimulation parameters

Study type

Interventional

Funder types

Industry

Identifiers

NCT01230151

017-0002

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.