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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01429220

Enrollment

Registered

2011-09-07

Start date

2011-08-31

Completion date

Unknown

Last updated

2014-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 90 Years

Healthy volunteers

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)

Countries

United States

Outcome results