Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS

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.

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Key information

Conditions

Parkinson's Disease With Deep Brain Stimulation

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cincinnati, Cincinnati, Ohio, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

Effect of DBS cessation on motor function over time

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Great Lakes NeuroTechnologies Inc.

Industry

Collaborators

National Institute on Aging (NIA)
University Hospitals Cleveland Medical Center
University of Cincinnati

Registry information

Important dates

Study start: 2014
Primary completion: 2014
First posted: Mar 6, 2014
Registry last updated: Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.