Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS

NCT ID: NCT02080572

Last Updated: 2015-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Brief Summary

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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

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Conditions

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Parkinson's Disease With Deep Brain Stimulation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Parkinson's Disease with DBS

Individuals with Parkinson's disease and deep brain stimulation will be recruited.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Great Lakes NeuroTechnologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph P Giuffrida, PhD

Role: PRINCIPAL_INVESTIGATOR

Great Lakes NeuroTechnologies

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

University Hospitals of Case Western

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2R44AG033947-03A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AG033947-03A1

Identifier Type: -

Identifier Source: org_study_id

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