Study Stopped
Funding not secured
Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 5, 2013
CompletedFirst Posted
Study publicly available on registry
December 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
April 1, 2021
CompletedMay 28, 2021
May 1, 2021
4.3 years
December 5, 2013
March 8, 2021
May 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Walking Speed
Walking speed will be measured using sensors reported in meter per second.
Up to 1 hour
Secondary Outcomes (3)
Stride Length
Up to 1 hour
UPDRS Scores
Up to 1 hour
TUG Test
Up to 1 hour
Study Arms (4)
Bilateral stimulation
EXPERIMENTALParticipants will receive Deep Brain Stimulation Bilaterally.
Left stimulation
EXPERIMENTALParticipants will receive Deep Brain Stimulation on the left side only
Right stimulation
EXPERIMENTALParticipants will receive Deep Brain Stimulation on the right side only
Off stimulation
NO INTERVENTIONParticipants will receive no brain stimulation
Interventions
DBS will provide brain stimulation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Corneliu Luca, MD, PhD
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Corneliu Luca, MD, PhD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Neurology
Study Record Dates
First Submitted
December 5, 2013
First Posted
December 30, 2013
Study Start
September 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
May 28, 2021
Results First Posted
April 1, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share