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Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait (STIMSYM)

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Unilateral reduction of stimulation
Chronic Subthalamic nucleus stimulation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Deep brain stimulation, Freezing of Gait

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients affiliated to social security Patient with idiopathic parkinson's disease, with deep brain stimulation since at least one year Freezing of gait Able to give inform consent

Exclusion Criteria:

Patient under guardianship, legal guardianship Psychosis Severe depression Severe cognitive troubles (Mattis < 130) Other neurologic or medical pathology interfering with gait

Sites / Locations

  • CHU Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chronic Subthalamic nucleus stimulation

Unilateral reduction of stimulation

Arm Description

This arm is the reference, with the best stimulation parameters

30% unilateral reduction of Subthalamic nucleus stimulation

Outcomes

Primary Outcome Measures

improvement of Freezing of gait
the improvement will be measure with a composite score of items 12 + 13 on UPDRS II and items 10+11 on UPDRS III,

Secondary Outcome Measures

Full Information

First Posted
March 4, 2016
Last Updated
September 20, 2016
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02704195
Brief Title
Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait
Acronym
STIMSYM
Official Title
Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease
Detailed Description
Unilateral modulation of subthalamic stimulation and its impact on freezing of gait in Parkinson's disease will be studied. In a cross-over, doubleblind, randomized study, a 30% reduction of stimulation intensity of the less impacted side will be compared with chronic treatment with regard to frequency and duration of freezing of gait episodes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, Deep brain stimulation, Freezing of Gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic Subthalamic nucleus stimulation
Arm Type
Active Comparator
Arm Description
This arm is the reference, with the best stimulation parameters
Arm Title
Unilateral reduction of stimulation
Arm Type
Experimental
Arm Description
30% unilateral reduction of Subthalamic nucleus stimulation
Intervention Type
Procedure
Intervention Name(s)
Unilateral reduction of stimulation
Intervention Description
30% unilateral reduction of Subthalamic nucleus stimulation
Intervention Type
Procedure
Intervention Name(s)
Chronic Subthalamic nucleus stimulation
Intervention Description
This arm is the reference, with the best stimulation parameters
Primary Outcome Measure Information:
Title
improvement of Freezing of gait
Description
the improvement will be measure with a composite score of items 12 + 13 on UPDRS II and items 10+11 on UPDRS III,
Time Frame
1 month after new stimulation parameters

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients affiliated to social security Patient with idiopathic parkinson's disease, with deep brain stimulation since at least one year Freezing of gait Able to give inform consent Exclusion Criteria: Patient under guardianship, legal guardianship Psychosis Severe depression Severe cognitive troubles (Mattis < 130) Other neurologic or medical pathology interfering with gait
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Moro, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Study Director
Facility Information:
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30826266
Citation
Meoni S, Debu B, Pelissier P, Scelzo E, Castrioto A, Seigneuret E, Chabardes S, Fraix V, Moro E. Asymmetric STN DBS for FOG in Parkinson's disease: A pilot trial. Parkinsonism Relat Disord. 2019 Jun;63:94-99. doi: 10.1016/j.parkreldis.2019.02.032. Epub 2019 Feb 25.
Results Reference
derived

Learn more about this trial

Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait

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