Parkinson's DiseaseCUSTOM-DBSNCT01896115
CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation
A study testing Vercise DBS settings in people with Parkinson's Disease, run by Boston Scientific Corporation at 10 sites in 5 countries.
Trial summary
The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Vercise DBS settings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesin 5 countries
- Study dates
- Jun 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Implanted bilaterally in STN with a Vercise DBS system for Parkinson's disease for at least three months with programming optimized according to standard of care.
- UPDRS subset III score of ≥30 in the in the pre-operative meds off state.
- DBS must improve PD symptoms by ≥30% in the meds off state, as measured by UPDRS subset III score.
- Medical and mental fitness to comply with programming visit and study related procedures.
- Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- Off symptom rigidity score of ≥2 in the evaluated arm as determined by the UPDRS-III.
Who cannot join
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
- Resting and/or action tremor score of ≥3 on the evaluated side as determined by the UPDRS-III in pre-operative meds off condition.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Germany5 sites
University Berlin, Charite Virchow
Berlin
Uniklinik Köln
Cologne
Universitaetsklinikum Dusseldorf
Düsseldorf
Universitatsklinikum Campus Kiel
Kiel
Universitaetsklinikum Wuerzburg
Würzburg
United Kingdom2 sites
Southmead Hospital Bristol
Bristol
Charing Cross Hospital
London
United States1 site
Boston Scientific Clinical Research Information toll free number
Valencia, California, 91355
About this study
Official title: Current Steering to Optimize Deep Brain Stimulation
The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.
Read the detailed description
The study is a prospective, multi-center, double-blind, randomized controlled trial.
This study will compare various program settings for the bilateral stimulation of the STN using the BSC implantable Vercise™ DBS System for the treatment of levodopa-responsive, moderate to severe idiopathic PD.
- Conditions
- Parkinson's Disease
- Being tested
- Vercise DBS settings
- Keywords
- Stimulation, implantable pulse generator, deep brain stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vercise DBS settingsDevice
Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
| Study group | Role | What they receive |
|---|---|---|
| Short PW | Experimental | Patients with a Vercise DBS system programmed to 30 microseconds pulse width Receives: Device: Vercise DBS settings |
| Conventional PW | Experimental | Patients with a Vercise DBS system programmed to 60 microseconds pulse width Receives: Device: Vercise DBS settings |
| Ventral current steering | Experimental | Patients with a Vercise DBS system programmed to steer current ventrally Receives: Device: Vercise DBS settings |
| Dorsal current steering | Experimental | Patients with a Vercise DBS system programmed to steer current dorsally. Receives: Device: Vercise DBS settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Window
The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, it is the amplitude difference between the first stimulation-induced side effect threshold (e.g., eye deviation, muscle contraction, and speech) and full rigidity control threshold at 60 µs and 30 µs pulse width DBS settings.
Measured: Day 1 programming visit
Unified Parkinson's Disease Rating Scale III
The Unified Parkinson's Disease Rating Scale (UPDRS) has four sections (I-IV) that ask patients to rate aspects of their mental state including mood (I), aspects of daily activities (II), aspects of motor function (III), and complications of treatment (IV). Here, we ask subjects to rate their motor function (UPDRS III) following interventions with 30 µs and 60 µs pulse width DBS settings.
The UPDRS III scale has 14 categories including speech, facial expression, tremor at rest, action tremor, rigidity, finger tapping ability, ability to open and close hands, ability to rapidly alternate hand movements, leg agility, ability to rise from a chair, posture, gait, response to postural displacement (e.g., push), and bradykinesia. Patients rate each of these categories from 0 to 4, with 0 being normal function and 4 being the worst. Categories assessing appendages are rated for both left and right sides, allowing a maximum score (worst outcome) of 108.
Measured: Day 1 programming visit
Secondary outcomes (3)
Side Effect Thresholds - Single Contact vs. Steering
This endpoint determined how much current (mA) could be applied before side effects appeared when using 60 microsecond pulse widths. Values were obtained for when current was delivered through a single contact or divided between two contacts (steering).
Measured: Day 1 programming visit
Resting Tremor Severity - Single Contact vs. Steering
Resting tremor was measured by a motion sensor system (Kinesia System) while either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).
Measured: Day 1 programming visit
Finger Tapping Amplitude - Single Contact vs. Steering
Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) when either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).
Measured: Day 1 programming visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roshini Jain, Study director, Boston Scientific Neuromodulation Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896115
- Sponsor's protocol ID
- A4009
- Other IDs
- CDM00060272
- Acronym
- CUSTOM-DBS
- Status last verified
- Nov 2020
- First submitted
- 24 Jun 2013
- Last updated
- 19 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Steering to Optimize Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT01896115
- Acronym / sponsor ID
- CUSTOM-DBS / A4009
- Conditions
- Parkinson's Disease
- Keywords
- Stimulation, implantable pulse generator, deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Posted 16 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.
Detailed description
The study is a prospective, multi-center, double-blind, randomized controlled trial.
This study will compare various program settings for the bilateral stimulation of the STN using the BSC implantable Vercise™ DBS System for the treatment of levodopa-responsive, moderate to severe idiopathic PD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Short PW | Experimental | Device: Vercise DBS settingsPatients with a Vercise DBS system programmed to 30 microseconds pulse width |
| Conventional PW | Experimental | Device: Vercise DBS settingsPatients with a Vercise DBS system programmed to 60 microseconds pulse width |
| Ventral current steering | Experimental | Device: Vercise DBS settingsPatients with a Vercise DBS system programmed to steer current ventrally |
| Dorsal current steering | Experimental | Device: Vercise DBS settingsPatients with a Vercise DBS system programmed to steer current dorsally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Implanted bilaterally in STN with a Vercise DBS system for Parkinson's disease for at least three months with programming optimized according to standard of care.
- UPDRS subset III score of ≥30 in the in the pre-operative meds off state.
- DBS must improve PD symptoms by ≥30% in the meds off state, as measured by UPDRS subset III score.
- Medical and mental fitness to comply with programming visit and study related procedures.
- Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Key exclusion criteria (2 listed)
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
- Resting and/or action tremor score of ≥3 on the evaluated side as determined by the UPDRS-III in pre-operative meds off condition.
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 |
|---|---|---|
| Vercise DBS settingsDeep brain stimulation set at short pulse width and monopolar stimulation using current steering | Device | Conventional PW, Dorsal current steering, Short PW, Ventral current steering |
Primary outcome
Therapeutic Window
Time frame: Day 1 programming visit
The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, it is the amplitude difference between the first stimulation-induced side effect threshold (e.g., eye deviation, muscle contraction, and speech) and full rigidity control threshold at 60 µs and 30 µs pulse width DBS settings.
Unified Parkinson's Disease Rating Scale III
Time frame: Day 1 programming visit
The Unified Parkinson's Disease Rating Scale (UPDRS) has four sections (I-IV) that ask patients to rate aspects of their mental state including mood (I), aspects of daily activities (II), aspects of motor function (III), and complications of treatment (IV). Here, we ask subjects to rate their motor function (UPDRS III) following interventions with 30 µs and 60 µs pulse width DBS settings. The UPDRS III scale has 14 categories including speech, facial expression, tremor at rest, action tremor, rigidity, finger tapping ability, ability to open and close hands, ability to rapidly alternate hand movements, leg agility, ability to rise from a chair, posture, gait, response to postural displacement (e.g., push), and bradykinesia. Patients rate each of these categories from 0 to 4, with 0 being normal function and 4 being the worst. Categories assessing appendages are rated for both left and right sides, allowing a maximum score (worst outcome) of 108.
3 secondary outcomes
Side Effect Thresholds - Single Contact vs. Steering
Time frame: Day 1 programming visit
Resting Tremor Severity - Single Contact vs. Steering
Time frame: Day 1 programming visit
Finger Tapping Amplitude - Single Contact vs. Steering
Time frame: Day 1 programming visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Roshini Jain study director
Boston Scientific Neuromodulation Corporation
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vercise DBS settings in people with Parkinson's Disease, run by Boston Scientific Corporation at 10 sites in 5 countries.
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 6 inclusion and 2 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, United Kingdom, United States, Austria, Italy. 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?
Yes. Results are posted in the registry (first posted 16 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Therapeutic Window (time frame: Day 1 programming visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2020.