Early Versus Late Application of STN DBS to PD Patients With Motor Complications

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

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2022-12-31

Brief Summary

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Although deep brain stimulation of the subthalamic nucleus(STN DBS) has become the surgical treatment of choice for Parkinson's disease(PD), a consensus on the timing of surgery is lacking. This study is intended to demonstrate that early, compared with delayed, introduction of STN DBS is more beneficial for PD patients who have developed motor complications.

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Detailed Description

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In this prospective study, 200 PD patients will be recruited for STN DBS over three years, including 133 with motor complications existing for more than three years (late complication group) and 67 less than three years (early complication group). To make a comparison of therapeutic efficacy between the two groups, motor and non-motor symptoms will be assessed using specific rating scales and questionnaires.

Conditions

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Parkinson Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Early Motor Complication

This group is composed of PD patients with motor complications of 3 years or less. All subjects receive bilateral deep brain stimulation of the subthalamic nucleus and best medical treatment.

Bilateral deep brain stimulation of the subthalamic nucleus

Intervention Type DEVICE

Late Motor Complication

This group is composed of PD patients with motor complications of more than 3 years. All subjects receive bilateral deep brain stimulation of the subthalamic nucleus and best medical treatment.

Bilateral deep brain stimulation of the subthalamic nucleus

Intervention Type DEVICE

Interventions

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Bilateral deep brain stimulation of the subthalamic nucleus

Intervention Type DEVICE

Other Intervention Names

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Activa PC or RC neurostimulator, Medtronic

Eligibility Criteria

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Inclusion Criteria

* Idiopathic Parkinson's Disease with good response to levodopa(i.e. more than 30% improvement in the MDS-UPDRS Part III score after an acute levodopa challenge)
* Presence of fluctuations and/or dyskinesias
* Age ranging from 18 to 75 years old
* Normal brain MRI
* Absence of dementia (Mini Mental State Examination ≥ 26)
* Absence of severe psychiatric diseases
* Written informed consent

Exclusion Criteria

* Presence of severe metabolic diseases
* Severe cardiac/respiratory/renal/hepatic diseases
* Secondary parkinsonism or multiple system atrophy
* Illiteracy or insufficient language skills to complete the questionnaires
* Poor compliance and unreasonable expectation
* Women who are pregnant or breast feeding
* Simultaneous participation in another clinical trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No