Back to resultsDeep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Deep Brain Stimulation
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
- Dementia
- Less than 45 years of age or older than 70 years of age
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Bilateral stimulation
Left stimulation
Right stimulation
Off stimulation
Arm Description
Participants will receive Deep Brain Stimulation Bilaterally.
Participants will receive Deep Brain Stimulation on the left side only
Participants will receive Deep Brain Stimulation on the right side only
Participants will receive no brain stimulation
Outcomes
Primary Outcome Measures
Walking Speed
Walking speed will be measured using sensors reported in meter per second.
Secondary Outcome Measures
Stride Length
Stride length will be measured using sensors and will be reported in meters.
UPDRS Scores
Unified Parkinson's disease rating Scale (UPDRS) has a total score ranging from 0-108 with the highest score indicating worse condition.
TUG Test
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02022735
Brief Title
Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease
Official Title
Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Funding not secured
Study Start Date
September 1, 2013 (undefined)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Deep Brain Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilateral stimulation
Arm Type
Experimental
Arm Description
Participants will receive Deep Brain Stimulation Bilaterally.
Arm Title
Left stimulation
Arm Type
Experimental
Arm Description
Participants will receive Deep Brain Stimulation on the left side only
Arm Title
Right stimulation
Arm Type
Experimental
Arm Description
Participants will receive Deep Brain Stimulation on the right side only
Arm Title
Off stimulation
Arm Type
No Intervention
Arm Description
Participants will receive no brain stimulation
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulator
Other Intervention Name(s)
DBS
Intervention Description
DBS will provide brain stimulation.
Primary Outcome Measure Information:
Title
Walking Speed
Description
Walking speed will be measured using sensors reported in meter per second.
Time Frame
Up to 1 hour
Secondary Outcome Measure Information:
Title
Stride Length
Description
Stride length will be measured using sensors and will be reported in meters.
Time Frame
Up to 1 hour
Title
UPDRS Scores
Description
Unified Parkinson's disease rating Scale (UPDRS) has a total score ranging from 0-108 with the highest score indicating worse condition.
Time Frame
Up to 1 hour
Title
TUG Test
Description
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.
Time Frame
Up to 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Dementia
Less than 45 years of age or older than 70 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corneliu Luca, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease
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