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

Parkinson Disease Clinical Trial

— IPOLAP  

Official title:

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

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

• Parkinson Disease

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