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

February 14, 2024 updated by: University Hospital, Clermont-Ferrand

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients :
  • Men or women aged between 45 -85 years
  • Patients with an idiopathic Parkinson's disease according to UKPDSBB criteria
  • Normal neurologic evaluation (except Parkinson's disease)
  • Patient treated with a deep brain stimulation according to the French consensus conference of treatment of Parkinson's disease (Consensus Conference Proceeding, 2000)
  • Affiliated to National Health system
  • Having given their informed consent

Healthy subject

  • Men or women aged between 45 -85 years
  • Normal neurologic evaluation
  • Affiliated to National Health system
  • Having given their informed consent

Exclusion Criteria:

  • Patients :
  • Patients suffering of an atypical Parkinson syndrome
  • Patients with locomotive disorders which can interfere in gait evaluation
  • Patients with dementia (MMS <24)
  • Under guardianship
  • In excluding period for another study
  • Person who participate to an other study

Healthy subject

  • Subject with locomotive disorders which can interfere in gait evaluation
  • Subject with dementia (MMS <24)
  • Under guardianship
  • In excluding period for another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: deep brain stimulation with high frequency
The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency vs low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).
Behavioral: deep brain stimulation
Other: low frequency on gait of patients
The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency vs low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).
Behavioral: deep brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The step length (expressed in meter)
Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
from day 1 (without L Dopa) to day 2 (with L Dopa)

Secondary Outcome Measures

Outcome Measure
Time Frame
The gait speed
Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
from day 1 (without L Dopa) to day 2 (with L Dopa)
The step cadence
Time Frame: From day 1 (without L Dopa) to day 2 (with L Dopa)
From day 1 (without L Dopa) to day 2 (with L Dopa)
The number of freezing
Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
from day 1 (without L Dopa) to day 2 (with L Dopa)
The UPDRS score
Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
from day 1 (without L Dopa) to day 2 (with L Dopa)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Emmanuel COUDEYRE, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

April 23, 2013

Study Completion (Actual)

April 23, 2013

Study Registration Dates

First Submitted

January 21, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimated)

February 4, 2013

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0140
  • 2011-A00892-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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