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

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
deep brain stimulation
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Deep brain stimulation, Gait, Freezing, Electrode placements

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

deep brain stimulation with high frequency

low frequency on gait of patients

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

The step length (expressed in meter)

Secondary Outcome Measures

The gait speed
The step cadence
The number of freezing
The UPDRS score

Full Information

First Posted
January 21, 2013
Last Updated
January 31, 2013
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT01782638
Brief Title
Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area
Official Title
Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

Brief 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Deep brain stimulation, Gait, Freezing, Electrode placements

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
deep brain stimulation with high frequency
Arm Type
Experimental
Arm Description
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).
Arm Title
low frequency on gait of patients
Arm Type
Other
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
deep brain stimulation
Primary Outcome Measure Information:
Title
The step length (expressed in meter)
Time Frame
from day 1 (without L Dopa) to day 2 (with L Dopa)
Secondary Outcome Measure Information:
Title
The gait speed
Time Frame
from day 1 (without L Dopa) to day 2 (with L Dopa)
Title
The step cadence
Time Frame
From day 1 (without L Dopa) to day 2 (with L Dopa)
Title
The number of freezing
Time Frame
from day 1 (without L Dopa) to day 2 (with L Dopa)
Title
The UPDRS score
Time Frame
from day 1 (without L Dopa) to day 2 (with L Dopa)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel COUDEYRE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Philippe DEROST

12. IPD Sharing Statement

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

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