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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Parkinson's Disease
Device: GUIDE software, Version 0.1
Device: Clinically defined stimulation parameters

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Sustained Affect of GUIDE (SAGE):A Software Evaluation Study

Resource links provided by NLM:


Further study details as provided by Intelect Medical, Inc.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 80
Study Start Date: December 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clinical
Stimulation settings predetermined clinically (Clinical)
Device: Clinically defined stimulation parameters
Stimulation parameters clinically determined prior to start of clinical study
Experimental: Model
stimulation settings derived from a patient-specific computer-based model (Model)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230151

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, Washington
Evergreen Healthcare
Kirkland, Washington, United States, 98034
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Intelect Medical, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Christopher R. Butson, Ph.D., Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01230151     History of Changes
Other Study ID Numbers: 017-0002
Study First Received: October 27, 2010
Last Updated: February 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Intelect Medical, Inc.:
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)

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 29, 2014