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

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Bilateral deep brain stimulation of the subthalamic nucleus

• Registration Number: NCT01922388
• Lead Sponsor: Chen Ling

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-11
• Study First Posted: 2013-08-14
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Late Motor Complication	Bilateral deep brain stimulation of the subthalamic nucleus	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.
Early Motor Complication	Bilateral deep brain stimulation of the subthalamic nucleus	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.

Primary Outcome Measures

Name	Time	Method
Changes in 39-item Parkinson's disease questionnaire (PDQ-39) scores	From baseline to 4 years	Quality of life

Secondary Outcome Measures

Name	Time	Method
Changes in time spent in the "on" state without troubling dyskinesia based on Parkinson's disease home diary	From baseline to 4 years	Good "on" time
Changes in Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores	From baseline to 4 years	Motor function
Severe adverse effects	From baseline to 4 years	Safety profile
Changes in MDS-UPDRS patient questionnaire (Part I B and Part II) scores	From baseline to 4 years	Motor and non-motor experiences of daily living

Trial Locations

Locations (1)

the First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China