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Clinical Trials/NCT02022735
NCT02022735
Terminated
Not Applicable

Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease

University of Miami1 site in 1 country22 target enrollmentSeptember 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
University of Miami
Enrollment
22
Locations
1
Primary Endpoint
Walking Speed
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the effect of Deep Brain stimulation (DBS) on walking in patients with Parkinson's disease that have had DBS. While DBS improves Parkinson's disease (PD) symptoms and walking in many patients in some of the patients walking problems persist. This study aims to find out what are the best stimulation parameters of the DBS in order to improve walking.

Registry
clinicaltrials.gov
Start Date
September 1, 2013
End Date
December 1, 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Corneliu C Luca

Assistant Professor of Neurology

University of Miami

Eligibility Criteria

Inclusion Criteria

  • Patients with idiopathic Parkinson's disease stage 1-3 that underwent subthalamic nucleus (STN) Deep Brain Stimulation (DBS) and have walking difficulties 6-12 months after DBS.
  • On stable dose of dopaminergic drugs
  • Age 45-70 years of age

Exclusion Criteria

  • Past medical history of seizures
  • Renal insufficiency
  • Cardiac arrhythmia
  • Severe arthritis
  • Women of childbearing potential
  • Less than 45 years of age or older than 70 years of age

Outcomes

Primary Outcomes

Walking Speed

Time Frame: Up to 1 hour

Walking speed will be measured using sensors reported in meter per second.

Secondary Outcomes

  • UPDRS Scores(Up to 1 hour)
  • Stride Length(Up to 1 hour)
  • TUG Test(Up to 1 hour)

Study Sites (1)

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