NCT01230151WithdrawnNot Applicable
Sustained Affect of GUIDE (SAGE):A Software Evaluation Study
Intelect Medical, Inc.8 sites in 1 country80 target enrollmentStarted: December 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 80
- Locations
- 8
- Primary Endpoint
- sustained improvement in working memory
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
sustained improvement in working memory
Time Frame: 2 Months
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 Outcomes
- Quality of Life (QOL)improvements(2 Months)
Investigators
Study Sites (8)
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