Parkinson DiseaseCLOVERNCT03037398

Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

A study testing Vercise Deep Brain Stimulation System in people with Parkinson Disease, run by Boston Scientific Corporation at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: Vercise Deep Brain Stimulation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 3 sitesGermany
Study dates: 11 Jan 2017to 2 Apr 2025
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 or GPi with a Vercise™ DBS system for Parkinson's disease, including directional leads, for at least four months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks.
Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Be at least 18 years of age.
Device must have been implanted on label or must be on label by the time the subject gets enrolled.

Who cannot join

Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

University Berlin, Charite Virchow Standort, Wedding
Berlin
Universitaetsklinik Eppendorf
Hamburg
Universitätsklinikum Campus Kiel
Kiel

Other trials in Germany

About this study

The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.

Conditions: Parkinson Disease
Being tested: Vercise Deep Brain Stimulation System
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 Deep Brain Stimulation SystemDevice

Study groups in NCT03037398
Study group	Role	What they receive
Novel Programming then Standard of Care (SOC) programming Arm	Experimental	Programming completed by a novel method first followed by Standard of care programming. Receives: Device: Vercise Deep Brain Stimulation System
Standard of Care Programming then Novel programming Arm	Experimental	Programming completed as Standard of care followed by Novel programming. Receives: Device: Vercise Deep Brain Stimulation System

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Motor Function
Mean change in Unified Parkinson's Disease Rating (UPDRS) Part III scores from Baseline meds off/stim off condition to Standard of care AND novel programming in meds off/stim on condition after randomization. Range 0 - 108. Higher scores indicate worse function.
Measured: Programming visit Day 1 after Randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 20172 Apr 2025

First posted31 Jan 2017 (estimated)
Study start11 Jan 2017
Primary completion2 Apr 2025
Study completion2 Apr 2025

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03037398
Sponsor's protocol ID: A4063
Acronym: CLOVER
Status last verified: Jul 2026
First submitted: 12 Jan 2017
Last updated: 5 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
ClinicalTrials.gov ID: NCT03037398
Acronym / sponsor ID: CLOVER / A4063
Conditions: Parkinson Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 11 Jan 2017 (actual)
Primary completion: 2 Apr 2025 (actual)
Study completion: 2 Apr 2025 (actual)
First posted: 31 Jan 2017 (estimated)
Results: Posted 5 Oct 2026

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 this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Novel Programming then Standard of Care (SOC) programming Arm	Experimental	Device: Vercise Deep Brain Stimulation SystemProgramming completed by a novel method first followed by Standard of care programming.
Standard of Care Programming then Novel programming Arm	Experimental	Device: Vercise Deep Brain Stimulation SystemProgramming completed as Standard of care followed by Novel programming.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Implanted bilaterally in STN or GPi with a Vercise™ DBS system for Parkinson's disease, including directional leads, for at least four months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks.
Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Be at least 18 years of age.
Device must have been implanted on label or must be on label by the time the subject gets enrolled.

Key exclusion criteria (1 listed)

Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.

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 Deep Brain Stimulation System	Device	Novel Programming then Standard of Care (SOC) programming Arm, Standard of Care Programming then Novel programming Arm

Primary outcome

Change in Motor Function
Time frame: Programming visit Day 1 after Randomization
Mean change in Unified Parkinson's Disease Rating (UPDRS) Part III scores from Baseline meds off/stim off condition to Standard of care AND novel programming in meds off/stim on condition after randomization. Range 0 - 108. Higher scores indicate worse function.

Results and safety

Results posted to the registry on 5 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care - Novel Algorithm Sequence	34	34
Novel Algorithm - Standard of Care Sequence	35	35

Primary outcome: Change in Motor Function

Time frame: Programming visit Day 1 after Randomization. Mean (Standard Deviation). Unit: Score on a scale

Measure	Standard of Care - Novel Algorithm Sequence n = 34	Novel Algorithm - SOC Sequence n = 35
Standard of Care vs Baseline Total UPDRS III Score Changes	13.8 (10.7)	16.5 (8.7)
Novel algorithm vs Baseline Total UPDRS III Score Changes	15.7 (8.6)	15.9 (7.8)

Population analysed: All subjects were randomized to receive all interventions. As such, all subjects are represented in one Arm/Group and analyzed together.

Adverse events

Time frame: Randomized subjects through the Programming visit Day 1. An average of 4-8 weeks for all subjects to complete study activities through the Programming visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care Programming	0 of 69 (0%)	2 of 69 (2.9%)	0 of 69
Novel Algorithm Programming	0 of 69 (0%)	0 of 69 (0%)	0 of 69

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Natalie Bloom Lyons study director

Boston Scientific Neuromodulation Corporation

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vercise Deep Brain Stimulation System in people with Parkinson Disease, run by Boston Scientific Corporation at 3 sites in Germany.

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 4 inclusion and 1 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 5 Oct 2026. 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 Germany. 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 5 Oct 2026). 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?

Change in Motor Function (time frame: Programming visit Day 1 after Randomization). 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 NCT03037398.

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 5 Oct 2026.