Parkinson DiseaseDIRECT-DBSNCT02835274
Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation
A study testing BSC Deep Brain Stimulation System with Directional Lead in people with Parkinson Disease, run by Boston Scientific Corporation at 3 sites in 3 countries.
Trial summary
The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- BSC Deep Brain Stimulation System with Directional Lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 19 Jul 2016to 19 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia.
- UPDRS III score of >25 in the meds OFF condition
- Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score
Who cannot join
- Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator
- Any current drug or alcohol abuse as determined by the investigator
- Any history of recurrent or unprovoked seizures
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation
The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.
- Conditions
- Parkinson Disease
- Being tested
- BSC Deep Brain Stimulation System with Directional Lead
- Keywords
- parkinson disease, deep brain stimulation, directional 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.
BSC Deep Brain Stimulation System with Directional LeadDevice
| Study group | Role | What they receive |
|---|---|---|
| Ring mode followed by Unrestricted mode | Experimental | omni-directional stimulation followed by unrestricted Mode stimulation Receives: Device: BSC Deep Brain Stimulation System with Directional Lead |
| Unrestricted mode followed by ring mode | Active comparator | Unrestricted Mode stimulation followed by omni-directional stimulation Receives: Device: BSC Deep Brain Stimulation System with Directional Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase
Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition
Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state
Measured: Up to 12 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start19 Jul 2016
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 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
- NCT02835274
- Sponsor's protocol ID
- A4150
- Acronym
- DIRECT-DBS
- Status last verified
- Nov 2020
- First submitted
- 24 Jun 2016
- 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
- Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT02835274
- Acronym / sponsor ID
- DIRECT-DBS / A4150
- Conditions
- Parkinson Disease
- Keywords
- parkinson disease, deep brain stimulation, directional stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2016 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Posted 7 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ring mode followed by Unrestricted mode | Experimental | Device: BSC Deep Brain Stimulation System with Directional Leadomni-directional stimulation followed by unrestricted Mode stimulation |
| Unrestricted mode followed by ring mode | Active comparator | Device: BSC Deep Brain Stimulation System with Directional LeadUnrestricted Mode stimulation followed by omni-directional stimulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia.
- UPDRS III score of >25 in the meds OFF condition
- Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score
Key exclusion criteria (4 listed)
- Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator
- Any current drug or alcohol abuse as determined by the investigator
- Any history of recurrent or unprovoked seizures
- 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
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 |
|---|---|---|
| BSC Deep Brain Stimulation System with Directional Lead | Device | Ring mode followed by Unrestricted mode, Unrestricted mode followed by ring mode |
Primary outcome
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase
Time frame: Up to 12 months post-implant
Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state
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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BSC Deep Brain Stimulation System with Directional Lead in people with Parkinson Disease, run by Boston Scientific Corporation at 3 sites in 3 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 3 inclusion and 4 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 3 sites in France, Germany, Netherlands. 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 7 Feb 2020). 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?
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase (time frame: Up to 12 months post-implant). 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.