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NCT Number: NCT01782638

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).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

deep brain stimulation

Behavioral

Primary outcomes

  1. The step length (expressed in meter)

    Time frame: from day 1 (without L Dopa) to day 2 (with L Dopa)

Secondary outcomes

  1. The gait speed

    Time frame: from day 1 (without L Dopa) to day 2 (with L Dopa)

  2. The step cadence

    Time frame: From day 1 (without L Dopa) to day 2 (with L Dopa)

  3. The number of freezing

    Time frame: from day 1 (without L Dopa) to day 2 (with L Dopa)

  4. The UPDRS score

    Time frame: from day 1 (without L Dopa) to day 2 (with L Dopa)

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2013
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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