Study Stopped
Not more patient with lateral deviation
Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?
IPOLAP
2 other identifiers
interventional
38
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Jan 2012
Longer than P75 for not_applicable parkinson-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 10, 2016
CompletedJune 22, 2016
June 1, 2016
3.4 years
February 20, 2012
June 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Lateropulsion measured by computerized Posturography
The postural inclination is measured in two conditions: With and without Deep Brain Stimulation. (Gissot et al., 2007).
4 days
Study Arms (2)
Voluntary subject
PLACEBO COMPARATORPatient without parkinson disease, without deep brain stimulation
Patients
ACTIVE COMPARATORSubthalamic stimulation
Interventions
Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU de Grenoble - Médecine Physique et de Réadapatation
Grenoble, 38043, France
CHU de Grenoble - Unité des troubles du mouvement
Grenoble, 38043, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul Krack, MD
University Hospital, Grenoble
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2012
First Posted
March 10, 2016
Study Start
January 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
June 22, 2016
Record last verified: 2016-06