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

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT01429220
• Lead Sponsor: Great Lakes NeuroTechnologies Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Primary Completion: 2014-04
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-12
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States