Study Stopped
Sponsor (Intelect Medical, Inc.) was acquired by Boston Scientific and study was canceled.
Feasibility Study to Evaluate Deep Brain Stimulation (DBS) Settings for the Treatment of Parkinson's Disease
SAGE
Sustained Affect of GUIDE (SAGE):A Software Evaluation Study
1 other identifier
interventional
80
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2010
CompletedFirst Posted
Study publicly available on registry
October 28, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedFebruary 18, 2011
February 1, 2011
1 year
October 27, 2010
February 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Quality of Life (QOL)improvements
2 Months
Study Arms (2)
Clinical
ACTIVE COMPARATORStimulation settings predetermined clinically (Clinical)
Model
EXPERIMENTALstimulation settings derived from a patient-specific computer-based model (Model)
Interventions
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.
Stimulation parameters clinically determined prior to start of clinical study
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Florida
Gainesville, Florida, 32610, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Evergreen Healthcare
Kirkland, Washington, 98034, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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. doi: 10.1093/brain/awp315. Epub 2010 Jan 7.
PMID: 20061324BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 27, 2010
First Posted
October 28, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2011
Last Updated
February 18, 2011
Record last verified: 2011-02