Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS

February 4, 2015 updated by: Great Lakes NeuroTechnologies Inc.
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Case Western

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Parkinson's Disease with DBS
Individuals with Parkinson's disease and deep brain stimulation will be recruited.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Great Lakes NeuroTechnologies Inc.

Collaborators

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

Investigators

  • Principal Investigator: Joseph P Giuffrida, PhD, Great Lakes NeuroTechnologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Estimate)

February 5, 2015

Last Update Submitted That Met QC Criteria

February 4, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG033947-03A1
  • 2R44AG033947-03A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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