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

NCT ID: NCT02022735

Last Updated: 2021-05-28

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-01

Study Completion Date

2017-12-01

Brief Summary

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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

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bilateral stimulation

Participants will receive Deep Brain Stimulation Bilaterally.

Group Type EXPERIMENTAL

Deep Brain Stimulator

Intervention Type DEVICE

DBS will provide brain stimulation.

Left stimulation

Participants will receive Deep Brain Stimulation on the left side only

Group Type EXPERIMENTAL

Deep Brain Stimulator

Intervention Type DEVICE

DBS will provide brain stimulation.

Right stimulation

Participants will receive Deep Brain Stimulation on the right side only

Group Type EXPERIMENTAL

Deep Brain Stimulator

Intervention Type DEVICE

DBS will provide brain stimulation.

Off stimulation

Participants will receive no brain stimulation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Deep Brain Stimulator

DBS will provide brain stimulation.

Intervention Type DEVICE

Other Intervention Names

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DBS

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Corneliu C Luca

Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Corneliu Luca, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20130225

Identifier Type: -

Identifier Source: org_study_id

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