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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

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


Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Subthalamic stimulation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?
Study Start Date : January 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704910


Locations
France
CHU de Grenoble - Médecine Physique et de Réadapatation
Grenoble, France, 38043
CHU de Grenoble - Unité des troubles du mouvement
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Study Director: Paul Krack, MD University Hospital, Grenoble

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02704910     History of Changes
Other Study ID Numbers: 1131
ID RCB ( Registry Identifier: 2011-A01533-38 )
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases