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

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Subthalamic stimulation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Voluntary subject

Patients

Arm Description

Patient without parkinson disease, without deep brain stimulation

Subthalamic stimulation

Outcomes

Primary Outcome Measures

Lateropulsion measured by computerized Posturography
The postural inclination is measured in two conditions: With and without Deep Brain Stimulation. (Gissot et al., 2007).

Secondary Outcome Measures

Full Information

First Posted
February 20, 2012
Last Updated
June 21, 2016
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02704910
Brief Title
Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?
Acronym
IPOLAP
Official Title
Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Not more patient with lateral deviation
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Voluntary subject
Arm Type
Placebo Comparator
Arm Description
Patient without parkinson disease, without deep brain stimulation
Arm Title
Patients
Arm Type
Active Comparator
Arm Description
Subthalamic stimulation
Intervention Type
Behavioral
Intervention Name(s)
Subthalamic stimulation
Intervention Description
Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus
Primary Outcome Measure Information:
Title
Lateropulsion measured by computerized Posturography
Description
The postural inclination is measured in two conditions: With and without Deep Brain Stimulation. (Gissot et al., 2007).
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Krack, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Grenoble - Médecine Physique et de Réadapatation
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHU de Grenoble - Unité des troubles du mouvement
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

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

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