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

Overview

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.

Full Title of Study: “Early Versus Late Application of Subthalamic Deep Brain Stimulation to Parkinson’s Disease Patients With Motor Complications: a Multicentre, Prospective and Observational Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2020

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.

Interventions

  • Device: Bilateral deep brain stimulation of the subthalamic nucleus

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Changes in 39-item Parkinson’s disease questionnaire (PDQ-39) scores
    • Time Frame: From baseline to 4 years
    • Quality of life

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chen Ling
  • Collaborator
    • Prince of Wales Hospital, Shatin, Hong Kong
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Chen Ling, MD, PhD – First Affiliated Hospital, Sun Yat-Sen University
  • Overall Official(s)
    • Ling Chen, MD, PhD, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
  • Overall Contact(s)
    • Ling Chen, MD, PhD, 0086-20-87332200, 1678270523@qq.com

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