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

Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429220
• Other study ID #: 5R44AG033520-03
• Status: Completed
• Phase: N/A
• First received: September 2, 2011
• Last updated: September 12, 2014
• Start date: August 2011

Study information

• Verified date: September 2014
• Source: Great Lakes NeuroTechnologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Great Lakes NeuroTechnologies Inc.

Country where clinical trial is conducted

United States,