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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01782638
First Posted: February 4, 2013
Last Update Posted: February 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose

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).


Condition Intervention Phase
Parkinson's Disease Behavioral: deep brain stimulation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area.

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • The step length (expressed in meter) [ Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa) ]

Secondary Outcome Measures:
  • The gait speed [ Time Frame: 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) ]
  • The number of freezing [ Time Frame: 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) ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782638


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sub-Investigator: Philippe DEROST         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Emmanuel COUDEYRE University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01782638     History of Changes
Other Study ID Numbers: CHU-0140
2011-A00892-39
First Submitted: January 21, 2013
First Posted: February 4, 2013
Last Update Posted: February 4, 2013
Last Verified: January 2013

Keywords provided by University Hospital, Clermont-Ferrand:
Parkinson's disease
Deep brain stimulation
Gait
Freezing
Electrode placements

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases