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

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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)
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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