Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS

Completed

• Conditions: Parkinson's Disease With Deep Brain Stimulation

• Registration Number: NCT02080572
• Lead Sponsor: Great Lakes NeuroTechnologies Inc.

Brief Summary

Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function, which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable movement sensors could be used to assess gait impairment in the patient's home hours after treatment adjustments are made in the clinic. This study aims to quantitatively evaluate the effects of turning off deep brain stimulation on lower extremity and gait function over three hours. This study will provide vital information about our patient worn system's ability to detect changes in lower impairment over time, which could be used to assist with DBS tuning for the lower extremities and gait in the future.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-06
• Primary Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Diagnosis of idiopathic Parkinson's disease
• Age > 21
• Underwent DBS surgery targeting the subthalamic nucleus (STN)
• Bilateral or midline involvement when "off" DBS/medication state
• Clinical history of gait impairment or freezing of gait

Exclusion Criteria

• "Parkinson's plus" syndrome, secondary, or atypical Parkinson's disease
• Underwent DBS surgery targeting the ventral intermediate (VIM)
• Unable to walk independent of a wheelchair (use of assistive devices, like a cane, is okay for this study)
• Dementia (determined by a neuropsychological assessment).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of DBS cessation on motor function over time	All data will be collected within a single session not to exceed 4 hours. All data will be analyzed within one month of study completion.	Motor function evaluations (movement speed and magnitude) will be collected at various time points after DBS cessation. The effects over time will be examined.

Trial Locations

Locations (2)

University Hospitals of Case Western; 🇺🇸 Cleveland, Ohio, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States