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

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ClinicalTrials.gov Identifier: NCT02704910
Recruitment Status : Terminated (Not more patient with lateral deviation)
First Posted : March 10, 2016
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

February 20, 2012
March 10, 2016
June 22, 2016
January 2012
June 2015   (Final data collection date for primary outcome measure)
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).
Lateropulsion mesured 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).
Complete list of historical versions of study NCT02704910 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?
Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?

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

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
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Parkinson Disease
Behavioral: Subthalamic stimulation
Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus
  • Placebo Comparator: Voluntary subject
    Patient without parkinson disease, without deep brain stimulation
    Intervention: Behavioral: Subthalamic stimulation
  • Active Comparator: Patients
    Subthalamic stimulation
    Intervention: Behavioral: Subthalamic stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
38
Same as current
June 2015
June 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT02704910
1131
ID RCB ( Registry Identifier: 2011-A01533-38 )
No
Not Provided
Not Provided
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Study Director: Paul Krack, MD University Hospital, Grenoble
University Hospital, Grenoble
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP