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

May 5, 2021 updated by: Corneliu C Luca, University of Miami
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

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
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

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

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Dementia
  • Less than 45 years of age or older than 70 years of age

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilateral stimulation
Participants will receive Deep Brain Stimulation Bilaterally.
Device: Deep Brain Stimulator
DBS will provide brain stimulation.
Other Names:
  • DBS
Experimental: Left stimulation
Participants will receive Deep Brain Stimulation on the left side only
Device: Deep Brain Stimulator
DBS will provide brain stimulation.
Other Names:
  • DBS
Experimental: Right stimulation
Participants will receive Deep Brain Stimulation on the right side only
Device: Deep Brain Stimulator
DBS will provide brain stimulation.
Other Names:
  • DBS
No Intervention: Off stimulation
Participants will receive no brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Speed
Time Frame: Up to 1 hour
Walking speed will be measured using sensors reported in meter per second.
Up to 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stride Length
Time Frame: Up to 1 hour
Stride length will be measured using sensors and will be reported in meters.
Up to 1 hour
UPDRS Scores
Time Frame: Up to 1 hour
Unified Parkinson's disease rating Scale (UPDRS) has a total score ranging from 0-108 with the highest score indicating worse condition.
Up to 1 hour
TUG Test
Time Frame: Up to 1 hour
Time Up and Go (TUG) Test reports the time it takes for participant to stand up from chair, walk around a cone and return to chair.
Up to 1 hour

Collaborators and Investigators

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

Sponsor

University of Miami

Investigators

  • Principal Investigator: Corneliu Luca, MD, PhD, University of Miami

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

September 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 27, 2013

First Posted (Estimate)

December 30, 2013

Study Record Updates

Last Update Posted (Actual)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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