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

Great Lakes NeuroTechnologies Inc.1 site in 1 country9 target enrollmentAugust 2011

ConditionsParkinson's Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Parkinson's Disease
Sponsor: Great Lakes NeuroTechnologies Inc.
Enrollment: 9
Locations: 1
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

April 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Great Lakes NeuroTechnologies Inc.

Responsible Party

Sponsor

Eligibility 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)