Trial record 14 of 133 for:    Deep Brain Stimulation for Parkinson's Disease

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01782638
First received: January 21, 2013
Last updated: January 31, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The gait speed [ Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa) ] [ Designated as safety issue: Yes ]
  • The step cadence [ Time Frame: From day 1 (without L Dopa) to day 2 (with L Dopa) ] [ Designated as safety issue: Yes ]
  • The number of freezing [ Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa) ] [ Designated as safety issue: Yes ]
  • The UPDRS score [ Time Frame: from day 1 (without L Dopa) to day 2 (with L Dopa) ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01782638     History of Changes
Other Study ID Numbers: CHU-0140, 2011-A00892-39
Study First Received: January 21, 2013
Last Updated: January 31, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014