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Clinical Trials/NCT02080572
NCT02080572
Completed
Not Applicable

Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS

Great Lakes NeuroTechnologies Inc.2 sites in 1 country22 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease With Deep Brain Stimulation
Sponsor
Great Lakes NeuroTechnologies Inc.
Enrollment
22
Locations
2
Primary Endpoint
Effect of DBS cessation on motor function over time
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
December 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

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.

Study Sites (2)

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