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

NCT01429220 | Completed

• 1 other identifier: 5R44AG033520-03
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

deep brain stimulation; monopolar review; motion sensors; tremor; bradykinesia

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's disease

You may qualify if:

• 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

You may not qualify if:

• "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)

Sponsors & Collaborators

• Great Lakes NeuroTechnologies Inc.: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Tremor; Hypokinesia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 7, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2014
• Last Updated: September 15, 2014

Record last verified: 2014-09

Locations

US (1)