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

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02704910
• Collaborator: (none)
• Enrollment: 38
• Locations: 2
• Arms: 2
• Duration (Months): 41
• Patients Per Site: 19
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jan 1, 2012
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Lateropulsion measured by computerized Posturography [4 days]

   The postural inclination is measured in two conditions: With and without Deep Brain Stimulation. (Gissot et al., 2007).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Grenoble - Médecine Physique et de Réadapatation	Grenoble		France	38043
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT02704910
• Other Study ID Numbers: 1131; ID RCB
• First Posted: Mar 10, 2016
• Last Update Posted: Jun 22, 2016
• Last Verified: Jun 1, 2016

• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Jun 22, 2016