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

Not Applicable

Withdrawn

• Conditions: Parkinson's Disease
• Interventions: Device: Clinically defined stimulation parameters; Device: GUIDE software, Version 0.1

• Registration Number: NCT01230151
• Lead Sponsor: Intelect Medical, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Study Start: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-17
• Last Update Posted: 2011-02-18
• Primary Completion: 2011-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clinical	Clinically defined stimulation parameters	Stimulation settings predetermined clinically (Clinical)
Model	GUIDE software, Version 0.1	stimulation settings derived from a patient-specific computer-based model (Model)

Primary Outcome Measures

Name	Time	Method
sustained improvement in working memory	2 Months	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).

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QOL)improvements	2 Months	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).

Trial Locations

Locations (4)

University of Florida; 🇺🇸 Gainesville, Florida, United States

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Evergreen Healthcare; 🇺🇸 Kirkland, Washington, United States