Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area
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
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
|---|---|
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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).
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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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The step length (expressed in meter)
Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
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from day 1 (without L Dopa) to day 2 (with L Dopa)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The gait speed
Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
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from day 1 (without L Dopa) to day 2 (with L Dopa)
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The step cadence
Time Frame: From day 1 (without L Dopa) to day 2 (with L Dopa)
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From day 1 (without L Dopa) to day 2 (with L Dopa)
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The number of freezing
Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
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from day 1 (without L Dopa) to day 2 (with L Dopa)
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The UPDRS score
Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa)
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from day 1 (without L Dopa) to day 2 (with L Dopa)
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Collaborators and Investigators
Investigators
- Principal Investigator: Emmanuel COUDEYRE, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0140
- 2011-A00892-39
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