Parkinson's DiseaseVOMPDSNCT01934881
Voltage Only Adjustment Versus Multiple Parameters Adjustment of Bilateral STN DBS Treatment in PD Patients.
An observational study of Parkinson's Disease, run by Chen Ling at 1 site in China.
Trial summary
The programming of subthalamic nucleus (STN) deep brain stimulation (DBS) for Parkinson's disease (PD) is complex work because the parameter setting has not been standardized so far. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- voltage adjustment only and Multiple parameters adjustment
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Sep 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: PD Patients are selected from the outpatient department of three centres.
Who may be able to join
- The patients with the idiopathic Parkinson's disease with good response to levodopa medication (i.e. more than 30% improvement in the MDS-UPDRS Part III score of the motor function examination(Goetz et al., 2008b) after an acute levodopa medication challenge);
- Disease duration ≥4 years;
- The patients with the fluctuations and/or dyskinesias;
- The patients with age ranging from 18 to 75 years old;
- The patients with normal brain on the MRI;
- The patients with the absence of dementia (Mini-Mental State Examination scores of≥ 26) ;
- The patients with the absence of severe psychiatric diseases;
- The patients who provided the written informed consent
Who cannot join
- The patients with severe metabolic diseases;
- The patients with severe cardiac/respiratory/renal/hepatic diseases;
- The patients having secondary parkinsonism or multiple system atrophies;
- The patients who illiterate or having insufficient language skills to complete the questionnaires;
- The patients who had poor compliance and unreasonable expectation;
- Women who were pregnant or breast feeding;
- The patients with the 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: Voltage Only Adjustment Versus Multiple Parameters Adjustment of Bilateral Subthalamic Deep Brain Stimulation Treatment in Parkinson's Disease Patients: a Protocol of a Prospective, Multicenter, and Observational Study.
The programming of subthalamic nucleus (STN) deep brain stimulation (DBS) for Parkinson's disease (PD) is complex work because the parameter setting has not been standardized so far. The objective of the present study is to set up a standardized programming algorithm for Chinese PD patients treated with bilateral STN DBS.
Read the detailed description
A total of 150 subjects will be recruited from the concurrent NCT01922388 study and followed up for four years. All patients will be evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III at baseline (one week before surgery) and at 12 and 48 months postoperatively.
Stimulation parameters setting: The first programming is performed at 4 weeks after surgery. Bilateral contacts are as cathode for monopolar configuration. The initial voltage, pulse width and frequency are bilaterally 1.0-1.5 V, 60 μs and 130 Hz for each individual, respectively. Voltage is gradually increased to a stable level first, until the optimal efficacy is achieved. Two weeks later, when patients came back to hospital for reprogramming, the voltage is also first adjusted to optimize the stimulation parameters. Either pulse width or frequency will be adjusted when increasing voltage more than 0.4 V for one time still can not get satisfactory outcomes. The frequency is adjusted when bilateral symptoms are unresponsive to voltage. Frequency is increased by 15-20 Hz for each time. Pulse width is then adjusted for the satisfactory clinical response of unilateral symptoms which are not satisfied after increasing voltage or frequency. Pulse width is increased to 90 μs if necessary (e.g. severe tremor).
Groups: Patients are divided into two groups according to the parameter settings during follow-up. Group I: patients with voltage adjustment only. The pulse width is kept to 60 μs and frequency to 130 Hz constant throughout the follow-up period. Group II: patients with adjustment of more than two stimulation parameters (voltage, pulse width or frequency) during the follow-up.
- Conditions
- Parkinson's Disease
- Being tested
- voltage adjustment only, Multiple parameters adjustment
- Keywords
- Deep Brain Stimulation, programming
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voltage adjustment onlyDevice
Only voltage will be adjusted in all programming sections.
Multiple parameters adjustmentDevice
More than one parameter, including voltage, frequency and pulse width, will be adjusted in the programming sections.
| Study group | Role | What they receive |
|---|---|---|
| group I | Voltage adjustment only Receives: Device: voltage adjustment only | |
| group II | Multiple parameters adjustment Receives: Device: Multiple parameters adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in motor symptoms (tremor, rigidity, bradykinesia and postural stability) evaluated by MDS-UPDRS Part III in off medication /on stimulation state
Motor subscores
Measured: From baseline to 12 and 48 months
Secondary outcomes (2)
Changes in 39-item Parkinson's Disease Questionnaire (PDQ-39) scores
Quality of life
Measured: From baseline to 12 and 48 months
Changes in levodopa equivalent daily dosage (LEDD)
Medication dosage
Measured: From baseline to 12 and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startSep 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's 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 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
- NCT01934881
- Sponsor's protocol ID
- [2013] 19
- Acronym
- VOMPDS
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2013
- Last updated
- 28 Sep 2023
- Results posted
- No
Publications
Xu SH, Yang C, Xian WB, Gu J, Liu JL, Jiang LL, Ye J, Liu YM, Guo QY, Zheng YF, Wu L, Chen WR, Pei Z, Chen L. Voltage adjustment improves rigidity and tremor in Parkinson's disease patients receiving deep brain stimulation. Neural Regen Res. 2018 Feb;13(2):347-352. doi: 10.4103/1673-5374.226406.
PubMed 29557387
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voltage Only Adjustment Versus Multiple Parameters Adjustment of Bilateral Subthalamic Deep Brain Stimulation Treatment in Parkinson's Disease Patients: a Protocol of a Prospective, Multicenter, and Observational Study.
- ClinicalTrials.gov ID
- NCT01934881
- Acronym / sponsor ID
- VOMPDS / [2013] 19
- Conditions
- Parkinson's Disease
- Keywords
- Deep Brain Stimulation, programming
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chen LingUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Shenzhen Second People's Hospital
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 4 Sep 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.
The programming of subthalamic nucleus (STN) deep brain stimulation (DBS) for Parkinson's disease (PD) is complex work because the parameter setting has not been standardized so far. The objective of the present study is to set up a standardized programming algorithm for Chinese PD patients treated with bilateral STN DBS.
Detailed description
A total of 150 subjects will be recruited from the concurrent NCT01922388 study and followed up for four years. All patients will be evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III at baseline (one week before surgery) and at 12 and 48 months postoperatively.
Stimulation parameters setting: The first programming is performed at 4 weeks after surgery. Bilateral contacts are as cathode for monopolar configuration. The initial voltage, pulse width and frequency are bilaterally 1.0-1.5 V, 60 μs and 130 Hz for each individual, respectively. Voltage is gradually increased to a stable level first, until the optimal efficacy is achieved. Two weeks later, when patients came back to hospital for reprogramming, the voltage is also first adjusted to optimize the stimulation parameters. Either pulse width or frequency will be adjusted when increasing voltage more than 0.4 V for one time still can not get satisfactory outcomes. The frequency is adjusted when bilateral symptoms are unresponsive to voltage. Frequency is increased by 15-20 Hz for each time. Pulse width is then adjusted for the satisfactory clinical response of unilateral symptoms which are not satisfied after increasing voltage or frequency. Pulse width is increased to 90 μs if necessary (e.g. severe tremor).
Groups: Patients are divided into two groups according to the parameter settings during follow-up. Group I: patients with voltage adjustment only. The pulse width is kept to 60 μs and frequency to 130 Hz constant throughout the follow-up period. Group II: patients with adjustment of more than two stimulation parameters (voltage, pulse width or frequency) during the follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | – | Device: voltage adjustment onlyVoltage adjustment only |
| group II | – | Device: Multiple parameters adjustmentMultiple parameters adjustment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PD Patients are selected from the outpatient department of three centres.
Key inclusion criteria (8 listed)
- The patients with the idiopathic Parkinson's disease with good response to levodopa medication (i.e. more than 30% improvement in the MDS-UPDRS Part III score of the motor function examination(Goetz et al., 2008b) after an acute levodopa medication challenge);
- Disease duration ≥4 years;
- The patients with the fluctuations and/or dyskinesias;
- The patients with age ranging from 18 to 75 years old;
- The patients with normal brain on the MRI;
Key exclusion criteria (7 listed)
- The patients with severe metabolic diseases;
- The patients with severe cardiac/respiratory/renal/hepatic diseases;
- The patients having secondary parkinsonism or multiple system atrophies;
- The patients who illiterate or having insufficient language skills to complete the questionnaires;
- The patients who had 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 |
|---|---|---|
| voltage adjustment onlyOnly voltage will be adjusted in all programming sections. | Device | group I |
| Multiple parameters adjustmentMore than one parameter, including voltage, frequency and pulse width, will be adjusted in the programming sections. | Device | group II |
Primary outcome
Changes in motor symptoms (tremor, rigidity, bradykinesia and postural stability) evaluated by MDS-UPDRS Part III in off medication /on stimulation state
Time frame: From baseline to 12 and 48 months
Motor subscores
2 secondary outcomes
Changes in 39-item Parkinson's Disease Questionnaire (PDQ-39) scores
Time frame: From baseline to 12 and 48 months
Changes in levodopa equivalent daily dosage (LEDD)
Time frame: From baseline to 12 and 48 months
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 28 Sep 2023.
- Derived from this study: PubMed 29557387Xu SH, Yang C, Xian WB, Gu J, Liu JL, Jiang LL, Ye J, Liu YM, Guo QY, Zheng YF, Wu L, Chen WR, Pei Z, Chen L. Voltage adjustment improves rigidity and tremor in Parkinson's disease patients receiving deep brain stimulation. Neural Regen Res. 2018 Feb;13(2):347-352. doi: 10.4103/1673-5374.226406.
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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's 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 8 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 28 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 motor symptoms (tremor, rigidity, bradykinesia and postural stability) evaluated by MDS-UPDRS Part III in off medication /on stimulation state (time frame: From baseline to 12 and 48 months). 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 NCT01934881, 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 28 Sep 2023.