Parkinson's Disease
Conditions
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)
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.
Interventions
DEVICEGUIDE 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.
DEVICEClinically defined stimulation parameters
Stimulation parameters clinically determined prior to start of clinical study
Sponsors
Intelect Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sustained improvement in working memory | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL)improvements | 2 Months | 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). |
Countries
United States
Outcome results
None listed