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NCT Number: NCT01922388

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

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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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral deep brain stimulation of the subthalamic nucleus

Device

Other names: Activa PC or RC neurostimulator, Medtronic

Primary outcomes

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

    Time frame: From baseline to 4 years

    Quality of life

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Severe adverse effects

    Time frame: From baseline to 4 years

    Safety profile

Sponsors and collaborators

Lead sponsor

Chen Ling

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ELASS

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2013
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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