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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02022735
Recruitment Status : Terminated (Funding not secured)
First Posted : December 30, 2013
Results First Posted : April 1, 2021
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Corneliu C Luca, University of Miami

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Deep Brain Stimulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease
Study Start Date : September 1, 2013
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bilateral stimulation
Participants will receive Deep Brain Stimulation Bilaterally.
Device: Deep Brain Stimulator
DBS will provide brain stimulation.
Other Name: 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 Name: 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 Name: DBS

No Intervention: Off stimulation
Participants will receive no brain stimulation



Primary Outcome Measures :
  1. Walking Speed [ Time Frame: Up to 1 hour ]
    Walking speed will be measured using sensors reported in meter per second.


Secondary Outcome Measures :
  1. Stride Length [ Time Frame: Up to 1 hour ]
    Stride length will be measured using sensors and will be reported in meters.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Dementia
  • Less than 45 years of age or older than 70 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022735


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Corneliu Luca, MD, PhD University of Miami
  Study Documents (Full-Text)

Documents provided by Corneliu C Luca, University of Miami:
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Responsible Party: Corneliu C Luca, Assistant Professor of Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT02022735    
Other Study ID Numbers: 20130225
First Posted: December 30, 2013    Key Record Dates
Results First Posted: April 1, 2021
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Corneliu C Luca, University of Miami:
Deep Brain Stimulation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases