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

NCT01922388 | Completed

• 1 other identifier: [2013]19
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; deep brain stimulation; subthalamic nucleus; motor complication; quality of life

Outcome Measures

Primary Outcomes (1)

• Changes in 39-item Parkinson's disease questionnaire (PDQ-39) scores

  Quality of life

  From baseline to 4 years

Secondary Outcomes (4)

• 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

• Changes in time spent in the "on" state without troubling dyskinesia based on Parkinson's disease home diary

  From baseline to 4 years

• Changes in MDS-UPDRS patient questionnaire (Part I B and Part II) scores

  From baseline to 4 years

• Severe adverse effects

  From baseline to 4 years

Study Arms (2)

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

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

Interventions

Bilateral deep brain stimulation of the subthalamic nucleus DEVICE

Also known as: Activa PC or RC neurostimulator, Medtronic

Early Motor Complication; Late Motor Complication

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chen Ling: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• Shenzhen Second People's Hospital: collaborator

Study Sites (1)

the First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• Jiang L, Poon WS, Moro E, Xian W, Yang C, Zhu XL, Gu J, Cai X, Liu J, Mok V, Liu Y, Xu S, Guo Q, Chen W, Chen L. Early versus Late Application of Subthalamic deep brain Stimulation to Parkinson's disease patients with motor complications (ELASS): protocol of a multicentre, prospective and observational study. BMJ Open. 2017 Nov 16;7(11):e018610. doi: 10.1136/bmjopen-2017-018610.

  PMID: 29150478 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ling Chen, MD, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 14, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

CN (1)