Parkinson DiseaseELASSNCT01922388
Early Versus Late Application of STN DBS to PD Patients With Motor Complications
An observational study of Parkinson Disease, run by Chen Ling at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Bilateral deep brain stimulation of the subthalamic nucleus
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population are PD Patients with motor complications and an intention of receiving DBS.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Bilateral deep brain stimulation of the subthalamic nucleus
- Keywords
- Parkinson disease, deep brain stimulation, subthalamic nucleus, motor complication, quality of life
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral deep brain stimulation of the subthalamic nucleusDevice
Also called Activa PC or RC neurostimulator, Medtronic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Bilateral deep brain stimulation of the subthalamic nucleus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 39-item Parkinson's disease questionnaire (PDQ-39) scores
Quality of life
Measured: 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
Motor function
Measured: From baseline to 4 years
Changes in time spent in the "on" state without troubling dyskinesia based on Parkinson's disease home diary
Good "on" time
Measured: From baseline to 4 years
Changes in MDS-UPDRS patient questionnaire (Part I B and Part II) scores
Motor and non-motor experiences of daily living
Measured: From baseline to 4 years
Severe adverse effects
Safety profile
Measured: From baseline to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chen Ling
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Shenzhen Second People's Hospital
- Responsible party
- Sponsor-investigator, Chen Ling, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Ling Chen, MD, PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922388
- Sponsor's protocol ID
- [2013]19
- Acronym
- ELASS
- Status last verified
- Sep 2023
- First submitted
- 8 Aug 2013
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29150478
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Application of Subthalamic Deep Brain Stimulation to Parkinson's Disease Patients With Motor Complications: a Multicentre, Prospective and Observational Study
- ClinicalTrials.gov ID
- NCT01922388
- Acronym / sponsor ID
- ELASS / [2013]19
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, deep brain stimulation, subthalamic nucleus, motor complication, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chen LingUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Shenzhen Second People's Hospital
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Motor Complication | – | Device: Bilateral deep brain stimulation of the subthalamic nucleusThis 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 | – | Device: Bilateral deep brain stimulation of the subthalamic nucleusThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are PD Patients with motor complications and an intention of receiving DBS.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral deep brain stimulation of the subthalamic nucleusAlso: Activa PC or RC neurostimulator, Medtronic | Device | Early Motor Complication, Late Motor Complication |
Primary outcome
Changes in 39-item Parkinson's disease questionnaire (PDQ-39) scores
Time frame: From baseline to 4 years
Quality of life
4 secondary outcomes
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
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
Changes in MDS-UPDRS patient questionnaire (Part I B and Part II) scores
Time frame: From baseline to 4 years
Severe adverse effects
Time frame: From baseline to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 29150478Jiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Chen, MD, PhD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Chen Ling at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 39-item Parkinson's disease questionnaire (PDQ-39) scores (time frame: From baseline to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.