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

This study has been withdrawn prior to enrollment.

(Sponsor (Intelect Medical, Inc.) was acquired by Boston Scientific and study was canceled.)

Sponsor:

Information provided by:

Intelect Medical, Inc.

ClinicalTrials.gov Identifier:

NCT01230151

First received: October 27, 2010

Last updated: February 17, 2011

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 27, 2010
Last Updated Date	February 17, 2011
Start Date ^ICMJE	December 2010
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 27, 2010)	sustained improvement in working memory [ Time Frame: 2 Months ] [ Designated as safety issue: No ] 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).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01230151 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 27, 2010)	Quality of Life (QOL)improvements [ Time Frame: 2 Months ] [ Designated as safety issue: No ] 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).
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Feasibility Study to Evaluate Deep Brain Stimulation (DBS) Settings for the Treatment of Parkinson's Disease
Official Title ^ICMJE	Sustained Affect of GUIDE (SAGE):A Software Evaluation Study
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care
Condition ^ICMJE	Parkinson's Disease
Intervention ^ICMJE	Device: GUIDE software, Version 0.1 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. Device: Clinically defined stimulation parameters Stimulation parameters clinically determined prior to start of clinical study
Study Arm (s)	Active Comparator: Clinical Stimulation settings predetermined clinically (Clinical) Intervention: Device: Clinically defined stimulation parameters Experimental: Model stimulation settings derived from a patient-specific computer-based model (Model) Intervention: Device: GUIDE software, Version 0.1
Publications *	Frankemolle AM, Wu J, Noecker AM, Voelcker-Rehage C, Ho JC, Vitek JL, McIntyre CC, Alberts JL. Reversing cognitive-motor impairments in Parkinson's disease patients using a computational modelling approach to deep brain stimulation programming. Brain. 2010 Mar;133(Pt 3):746-61. Epub 2010 Jan 7.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Estimated Enrollment ^ICMJE	80
Completion Date	Not Provided
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01230151
Other Study ID Numbers ^ICMJE	017-0002
Has Data Monitoring Committee	No
Responsible Party	Christopher R. Butson, Ph.D., Medical College of Wisconsin
Study Sponsor ^ICMJE	Intelect Medical, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Intelect Medical, Inc.
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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