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This study has been withdrawn prior to enrollment.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

October 27, 2010
February 17, 2011
December 2010
December 2011   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01230151 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Feasibility Study to Evaluate Deep Brain Stimulation (DBS) Settings for the Treatment of Parkinson's Disease
Sustained Affect of GUIDE (SAGE):A Software Evaluation Study

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.

Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Parkinson's Disease
  • 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
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
80
Not Provided
December 2011   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01230151
017-0002
No
Christopher R. Butson, Ph.D., Medical College of Wisconsin
Intelect Medical, Inc.
Not Provided
Not Provided
Intelect Medical, Inc.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP