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Automated Parkinson's Disease (PD) Motor Symptom Assessment for Deep Brain Stimulation (DBS) Programming

This study is currently recruiting participants.
Verified June 2012 by Great Lakes NeuroTechnologies Inc.
Sponsor:
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier:
NCT01429220
First received: September 2, 2011
Last updated: June 27, 2012
Last verified: June 2012
History of Changes

September 2, 2011
June 27, 2012
August 2011
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Complete list of historical versions of study NCT01429220 on ClinicalTrials.gov Archive Site
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Automated Parkinson's Disease (PD) Motor Symptom Assessment for Deep Brain Stimulation (DBS) Programming
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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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Parkinson's disease
Parkinson's Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
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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)
Both
21 Years to 90 Years
No
Contact: Jerrold Vitek, MD, PhD 612-625-5993 vitek004@umn.edu
United States
 
NCT01429220
5R44AG033520-03
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Great Lakes NeuroTechnologies Inc.
Great Lakes NeuroTechnologies Inc.
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Not Provided
Great Lakes NeuroTechnologies Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP