Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait
STIMSYM
1 other identifier
interventional
12
1 country
1
Brief Summary
Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 4, 2016
CompletedFirst Posted
Study publicly available on registry
March 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedSeptember 21, 2016
September 1, 2016
2 years
March 4, 2016
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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,
1 month after new stimulation parameters
Study Arms (2)
Chronic Subthalamic nucleus stimulation
ACTIVE COMPARATORThis arm is the reference, with the best stimulation parameters
Unilateral reduction of stimulation
EXPERIMENTAL30% unilateral reduction of Subthalamic nucleus stimulation
Interventions
30% unilateral reduction of Subthalamic nucleus stimulation
This arm is the reference, with the best stimulation parameters
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient under guardianship, legal guardianship Psychosis Severe depression Severe cognitive troubles (Mattis \< 130) Other neurologic or medical pathology interfering with gait
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Grenoble
Grenoble, 38043, France
Related Publications (1)
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.
PMID: 30826266DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elena Moro, MD
University Hospital, Grenoble
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2016
First Posted
March 9, 2016
Study Start
April 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
September 21, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share