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

NCT ID: NCT02704910

Last Updated: 2016-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Voluntary subject

Patient without parkinson disease, without deep brain stimulation

Group Type PLACEBO_COMPARATOR

Subthalamic stimulation

Intervention Type BEHAVIORAL

Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus

Patients

Subthalamic stimulation

Group Type ACTIVE_COMPARATOR

Subthalamic stimulation

Intervention Type BEHAVIORAL

Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus

Interventions

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Subthalamic stimulation

Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Krack, MD

Role: STUDY_DIRECTOR

University Hospital, Grenoble

Locations

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CHU de Grenoble - Médecine Physique et de Réadapatation

Grenoble, , France

Site Status

CHU de Grenoble - Unité des troubles du mouvement

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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ID RCB

Identifier Type: REGISTRY

Identifier Source: secondary_id

1131

Identifier Type: -

Identifier Source: org_study_id

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