Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait

NCT ID: NCT02704195

Last Updated: 2016-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Chronic Subthalamic nucleus stimulation

This arm is the reference, with the best stimulation parameters

Group Type ACTIVE_COMPARATOR

Chronic Subthalamic nucleus stimulation

Intervention Type PROCEDURE

This arm is the reference, with the best stimulation parameters

Unilateral reduction of stimulation

30% unilateral reduction of Subthalamic nucleus stimulation

Group Type EXPERIMENTAL

Unilateral reduction of stimulation

Intervention Type PROCEDURE

30% unilateral reduction of Subthalamic nucleus stimulation

Interventions

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Unilateral reduction of stimulation

30% unilateral reduction of Subthalamic nucleus stimulation

Intervention Type PROCEDURE

Chronic Subthalamic nucleus stimulation

This arm is the reference, with the best stimulation parameters

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Moro, MD

Role: STUDY_DIRECTOR

University Hospital, Grenoble

Locations

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CHU Grenoble

Grenoble, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 30826266 (View on PubMed)

Other Identifiers

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2013-A01323-42

Identifier Type: -

Identifier Source: org_study_id

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