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

Study Overview
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Brief Summary
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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.

Official Title
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Sustained Affect of GUIDE (SAGE):A Software Evaluation Study

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: GUIDE software, Version 0.1
* Device: Clinically defined stimulation parameters


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinical<br>Stimulation settings predetermined clinically (Clinical) | Device: Clinically defined stimulation parameters<br>* Stimulation parameters clinically determined prior to start of clinical study<br>|
| Experimental: Model<br>stimulation settings derived from a patient-specific computer-based model (Model) | Device: GUIDE software, Version 0.1<br>* The GUIDE software uses computer-based models to determine the spread of stimulation from DBS therapy into surrounding nuclei of the brain. The software models stimulation and is not used to program or communicate with the patient's implanted DBS System. The software was recently validated in a multi-center clinical study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained improvement in working memory | The primary endpoint of this study is to determine whether or not sustained improvement in working memory can be obtained during DBS with stimulation settings derived from a patient-specific computer-based model (Model) as compared with stimulation settings predetermined clinically (Clinical). | 2 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL)improvements | The secondary endpoints will evaluate whether or not sustained cognitive improvements translate into other aspects of the patient's life (e.g. mood, activities of daily living, apathy, etc.) during DBS with stimulation settings derived from a patient-specific computer-based model (Model) as compared with stimulation settings predetermined clinically (Clinical). | 2 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation, DBS, Parkinson's disease, PD, Patients who have a preexisting Deep Brain Stimulation (DBS) system for the treatment of Parkinson's disease (PD)