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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

Tracking Information
First Submitted Date  ICMJE February 20, 2012
First Posted Date  ICMJE March 10, 2016
Last Update Posted Date June 22, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2016)
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).
Change History Complete list of historical versions of study NCT02704910 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?
Official Title  ICMJE Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Behavioral: Subthalamic stimulation
Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 4, 2016)
38
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02704910
Other Study ID Numbers  ICMJE 1131
ID RCB ( Registry Identifier: 2011-A01533-38 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul Krack, MD University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date June 2016

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