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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02022735
• Other study ID #: 20130225
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2013
• Est. completion date: December 1, 2017

Study information

• Verified date: May 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Deep Brain Stimulator
DBS will provide brain stimulation.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking Speed	Walking speed will be measured using sensors reported in meter per second.	Up to 1 hour
Secondary	Stride Length	Stride length will be measured using sensors and will be reported in meters.	Up to 1 hour
Secondary	UPDRS Scores	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
Secondary	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.	Up to 1 hour