Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area

Parkinson's Disease Clinical Trial

Official title: Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area.

Status Completed

Clinical Trial Summary

Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a diffusion of the electric stimulation current to the fibbers going near STN area.

The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency versus low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).

Clinical Trial Description

A randomized, double-blind, parallel-group study 2 groups of patients: 10 patients with electrodes placed in STN and 10 patients with electrodes placed in Forel fields.

1 group of healthy paired-control (n=20).

Patients will be evaluated without and with treatment on two mornings (J0 and J0+1day).

In each condition of treatment, 3 conditions of stimulation were tested: without stimulation; frequency 25Hz, frequency 130 Hz.

Evaluations consist on :

• motor evaluation (UPDRS)

• gait evaluation (to walk on a gait mat)

• Stand-Walk-Sit Test ;

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

• NCT number: NCT01782638
• Study type: Interventional
• Source: University Hospital, Clermont-Ferrand
• Status: Completed
• Phase: Phase 4
• Start date: September 2012
• Completion date: April 23, 2013