Clinical trial NCT01230151: Feasibility Study to Evaluate Deep Brain Stimulation (DBS) Settings for the Treatment of Parkinson's Disease
Official title: Sustained Affect of GUIDE (SAGE):A Software Evaluation Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: 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)
Lead sponsor: Intelect Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-28
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: sustained improvement in working memory
timeFrame: 2 Months
Secondary outcomes:
measure: Quality of Life (QOL)improvements
timeFrame: 2 Months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Kirkland
country: United States
facility: Evergreen Healthcare
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: 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.