Automated Parkinson's Disease (PD) Motor Symptom Assessment for Deep Brain Stimulation (DBS) Programming
Status: | Recruiting |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 21 - 90 |
Updated: | 11/30/2013 |
Start Date: | August 2011 |
Contact: | Jerrold Vitek, MD, PhD |
Email: | vitek004@umn.edu |
Phone: | 612-625-5993 |
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.
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)
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