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

Not Applicable

Terminated

• Conditions: Parkinson's Disease
• Interventions: Device: Deep Brain Stimulator

• Registration Number: NCT02022735
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-01
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-27
• Study First Posted: 2013-12-30
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Results First Submitted: 2021-03-08
• Results First Submitted QC: 2021-03-08
• Results First Posted: 2021-04-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bilateral stimulation	Deep Brain Stimulator	Participants will receive Deep Brain Stimulation Bilaterally.
Left stimulation	Deep Brain Stimulator	Participants will receive Deep Brain Stimulation on the left side only
Right stimulation	Deep Brain Stimulator	Participants will receive Deep Brain Stimulation on the right side only

Primary Outcome Measures

Name	Time	Method
Walking Speed	Up to 1 hour	Walking speed will be measured using sensors reported in meter per second.

Secondary Outcome Measures

Name	Time	Method
UPDRS Scores	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.
Stride Length	Up to 1 hour	Stride length will be measured using sensors and will be reported in meters.
TUG Test	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States