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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
  Purpose

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.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Great Lakes NeuroTechnologies Inc.:

Estimated Enrollment: 15
Study Start Date: August 2011
  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Parkinson's disease

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429220

Contacts
Contact: Jerrold Vitek, MD, PhD 612-625-5993 vitek004@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Diane Kachel     612-626-6158     kach0034@umn.edu    
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
  More Information

No publications provided

Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT01429220     History of Changes
Other Study ID Numbers: 5R44AG033520-03
Study First Received: September 2, 2011
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Great Lakes NeuroTechnologies Inc.:
deep brain stimulation
monopolar review
motion sensors
tremor
bradykinesia

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 16, 2013