Unknown statusInterventionalNot ApplicableUpdated Jun 27, 2019
Automated Parkinson's Disease (PD) Motor Symptom Assessment for Deep Brain Stimulation (DBS) Programming | NCT01429220 | Trialant
CompletedObservationalUpdated Sep 15, 2014
Automated Parkinson's Disease (PD) Motor Symptom Assessment for Deep Brain Stimulation (DBS) Programming
ClinicalTrials.gov ID
NCT01429220
Lead Sponsor
Great Lakes NeuroTechnologies Inc.INDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
9Actual
Last Update Posted
Sep 15, 2014Estimated
Start Date
Aug 2011
Primary Completion Date
Apr 2014Actual
Brief Summary
The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to assist with deep brain stimulation (DBS) programming sessions for Parkinson's disease patients.
Parkinson's Disease
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hoehn and Yahr stage 2 or worse when off medications
Average tremor and/or bradykinesia Unified Disease Rating Scale (UPDRS) score greater than 2 off meds
L-dopa responsive with clearly defined "on" periods, UPDRS motor III average tremor and bradykinesia improves by 25%
Stable on medical therapy for at least one month prior to study enrollment
Clinical approval to undergo unilateral DBS surgery targeting the STN or GPi
Available to participate for six months following DBS surgery
Exclusion Criteria:
"Parkinson's plus" syndromes, secondary, or atypical Parkinson's syndromes (e.g. progressive supranuclear palsy, striato-nigral degeneration, multiple system atrophy, post-stroke, post-traumatic, or post-encephalitic Parkinson's. These patients have cardinal symptoms characteristic of PD but with additional symptoms indicating other organic brain dysfunction, such as gaze palsies, autonomic dysfunction, lack of response to L-dopa, these individuals tend not to improve with standard treatments for PD)
previous Parkinson's Disease surgery
medical contraindications to surgery or stimulation (e.g. uncontrolled hypertension, advanced coronary artery disease, other implanted stimulation or electronically-controlled devices including cardiac demand pacemaker, aneurysm clips, cochlear implants, or a spinal cord stimulator) (Note: for the subject who receives either a pacemaker and/or defibrillator after this study enrollment, he/she will be allowed to continue the study if the neurostimulator system can be adequately programmed to permit system compatibility)
contraindication to magnetic resonance imaging (e.g. indwelling metal fragments or implants that might be affected by MRI)
neuropsychological dysfunction (e.g. dementia) that would contraindicate surgery
intracranial abnormalities that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the target area)