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

September 25, 2023 updated by: Chen Ling

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ling Chen, MD, PhD
  • Phone Number: 8253 0086-20-87332200
  • Email: 1678270523@qq.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population are PD Patients with motor complications and an intention of receiving DBS.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Bilateral deep brain stimulation of the subthalamic nucleus
Other Names:
  • Activa PC or RC neurostimulator, Medtronic
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.
Device: Bilateral deep brain stimulation of the subthalamic nucleus
Other Names:
  • Activa PC or RC neurostimulator, Medtronic

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to 4 years
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
From baseline to 4 years
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
From baseline to 4 years
Severe adverse effects
Time Frame: From baseline to 4 years
Safety profile
From baseline to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chen Ling

Collaborators

Prince of Wales Hospital, Shatin, Hong Kong
Shenzhen Second People's Hospital

Investigators

  • Principal Investigator: Ling Chen, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 11, 2013

First Posted (Estimated)

August 14, 2013

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2013]19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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