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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02704910
Other study ID # 1131
Secondary ID ID RCB
Status Terminated
Phase N/A
First received February 20, 2012
Last updated June 21, 2016
Start date January 2012
Est. completion date June 2015

Study information

Verified date June 2016
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Terminated
Enrollment 38
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHU de Grenoble - Médecine Physique et de Réadapatation Grenoble
France CHU de Grenoble - Unité des troubles du mouvement Grenoble

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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