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This study has been withdrawn prior to enrollment.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:
Intelect Medical, Inc.
Information provided by:
Intelect Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01230151
First received: October 27, 2010
Last updated: February 17, 2011
Last verified: February 2011
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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
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 May 19, 2013