Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait

Parkinson Disease Clinical Trial

— STIMSYM  

Official title:

Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02704195
• Other study ID #: 2013-A01323-42
• Status: Terminated
• Phase: N/A
• First received: March 4, 2016
• Last updated: September 20, 2016
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Unilateral reduction of stimulation
30% unilateral reduction of Subthalamic nucleus stimulation
• Chronic Subthalamic nucleus stimulation
This arm is the reference, with the best stimulation parameters

Locations

Country	Name	City	State
France	CHU Grenoble	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	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	Yes