NCT02080572

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

10 months

First QC Date

March 4, 2014

Last Update Submit

February 4, 2015

Conditions

Parkinson's Disease With Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

  • Effect of DBS cessation on motor function over time

    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.

Study Arms (1)

Parkinson's Disease with DBS

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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • "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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Cincinnati

Cincinnati, Ohio, 45220, United States

Location

University Hospitals of Case Western

Cleveland, Ohio, 44106, United States

Location

Study Officials

  • Joseph P Giuffrida, PhD

    Great Lakes NeuroTechnologies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

US(2)