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

University of Miami

Status: Terminated

Conditions: Parkinson's Disease

Treatments: Device: Deep Brain Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT02022735

20130225

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 4 patient groups

Bilateral stimulation

Experimental group

Description:

Participants will receive Deep Brain Stimulation Bilaterally.

Treatment:

Device: Deep Brain Stimulator

Left stimulation

Experimental group

Description:

Participants will receive Deep Brain Stimulation on the left side only

Treatment:

Device: Deep Brain Stimulator

Right stimulation

Experimental group

Description:

Participants will receive Deep Brain Stimulation on the right side only

Treatment:

Device: Deep Brain Stimulator

Off stimulation

No Intervention group

Description:

Participants will receive no brain stimulation