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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782638
• Other study ID #: CHU-0140
• Secondary ID: 2011-A00892-39
• Status: Completed
• Phase: Phase 4
• Start date: September 2012
• Est. completion date: April 23, 2013

Study information

• Verified date: January 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 23, 2013
• Est. primary completion date: April 23, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• deep brain stimulation

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The step length (expressed in meter)		from day 1 (without L Dopa) to day 2 (with L Dopa)
Secondary	The gait speed		from day 1 (without L Dopa) to day 2 (with L Dopa)
Secondary	The step cadence		From day 1 (without L Dopa) to day 2 (with L Dopa)
Secondary	The number of freezing		from day 1 (without L Dopa) to day 2 (with L Dopa)
Secondary	The UPDRS score		from day 1 (without L Dopa) to day 2 (with L Dopa)