Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ? (IPOLAP)

June 21, 2016 updated by: University Hospital, Grenoble

The objective of this study is to assess the origins of lateral postural inclination presented by some Parkinson disease's patients.

Several mechanisms could cause lateral postural inclination. Available data allow to suggest three hypothesis: (troubles of tonus, perception of vertical perturbation, trouble of perception of corporal axis

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Inclusion Criteria:

  • 30 to 75 years old patient
  • Parkinson disease's diagnosed since 5 years
  • Treated by deep brain stimulation
  • Patient with at least 6 degree lateral deviation
  • Without vestibular troubles nor peripheral sensorial trouble.

Exclusion Criteria:

  • Dementia (Mattis < 130 ou MMS <24), or severe depressive episode according to DSM IV-R criteria
  • Camptocormia or incompatible anteflexion with the dispositive of measure device
  • Pregnant woman, nursing mother

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU de Grenoble - Médecine Physique et de Réadapatation
      • Grenoble, France, 38043
        • CHU de Grenoble - Unité des troubles du mouvement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 30 to 75 years old patient
  • Parkinson disease's diagnosed since 5 years
  • Treated by deep brain stimulation
  • Patient with at least 6 degree lateral deviation
  • Without vestibular troubles nor peripheral sensorial trouble.

Exclusion Criteria:

  • Dementia (Mattis < 130 ou MMS <24), or severe depressive episode according to DSM IV-R criteria
  • Camptocormia or incompatible anteflexion with the dispositive of measure device
  • Pregnant woman, nursing mother

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Voluntary subject
Patient without parkinson disease, without deep brain stimulation
Behavioral: Subthalamic stimulation
Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus
Active Comparator: Patients
Subthalamic stimulation
Behavioral: Subthalamic stimulation
Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lateropulsion measured by computerized Posturography
Time Frame: 4 days
The postural inclination is measured in two conditions: With and without Deep Brain Stimulation. (Gissot et al., 2007).
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Study Director: Paul Krack, MD, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 20, 2012

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1131
  • Id RCB (Registry Identifier: 2018-A00771-54)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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