Parkinson's Disease (PD)RESET-DBSNCT03732898
Coordinated Reset Deep Brain Stimulation
A study testing Novel Programming (nDBS) and Conventional Programming (cDBS) in people with Parkinson's Disease (PD), run by Boston Scientific Corporation at 2 sites in Germany.
Trial summary
The study will explore the viability of an alternative/novel programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- Novel Programming (nDBS) and Conventional Programming (cDBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesGermany
- Study dates
- 13 Jan 2019to 12 Nov 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject with PD implanted bilaterally in the STN and receiving DBS therapy for at least 3 months.
- Tolerates > 12 hours OFF medication and, per clinical judgment, be able to perform all study related procedures.
- Able to understand the study requirements and the treatment procedures and must provide written informed consent before any study-specific tests or procedures are performed.
Who cannot join
- Exhibits significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
- A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Berlin, Charite Virchow
Berlin
Universitaetsklinikum Wuerzburg
Würzburg
About this study
Official title: Coordinated Reset Deep Brain Stimulation (RESET-DBS) and RESET-DBS - Extension (Sub-study)
The study will explore the viability of an alternative/novel programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).
Read the detailed description
The study will explore the feasibility of utilizing an alternative/novel programming technique in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).
- Conditions
- Parkinson's Disease (PD)
- Being tested
- Novel Programming (nDBS), Conventional Programming (cDBS)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Programming (nDBS)Device
The commercial CP installed with the investigational DBS programming software will be used to set up Novel Programming (nDBS) therapy on the IPG.
Conventional Programming (cDBS)Device
The commercial CP installed with commercial software will be used to set up standard cDBS therapy on the IPG.
| Study group | Role | What they receive |
|---|---|---|
| Novel Deep Brain Stimulation (nDBS) program | Experimental | This arm will include patients receiving stimulation with a novel Deep Brain Stimulation (nDBS) for Parkinson's Disease (PD). Receives: Device: Novel Programming (nDBS) |
| Conventional Deep Brain Stimulation (cDBS) program | Active comparator | This arm will include patients receiving stimulation with a conventional Deep Brain Stimulation (cDBS) for Parkinson's Disease (PD). Receives: Device: Conventional Programming (cDBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Quality of Life using new programming paradigm: PDQ-39
Change in Parkinson's Disease Questionnaire (PDQ-39) summary index and sub-scores
Measured: approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start13 Jan 2019
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie Bloom Lyons, Study director, Boston Scientific Neuromodulation Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732898
- Sponsor's protocol ID
- A4058
- Acronym
- RESET-DBS
- Status last verified
- Dec 2025
- First submitted
- 30 Oct 2018
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinated Reset Deep Brain Stimulation (RESET-DBS) and RESET-DBS - Extension (Sub-study)
- ClinicalTrials.gov ID
- NCT03732898
- Acronym / sponsor ID
- RESET-DBS / A4058
- Conditions
- Parkinson's Disease (PD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2019 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 7 Nov 2018 (actual)
- 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 study will explore the viability of an alternative/novel programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).
Detailed description
The study will explore the feasibility of utilizing an alternative/novel programming technique in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel Deep Brain Stimulation (nDBS) program | Experimental | Device: Novel Programming (nDBS)This arm will include patients receiving stimulation with a novel Deep Brain Stimulation (nDBS) for Parkinson's Disease (PD). |
| Conventional Deep Brain Stimulation (cDBS) program | Active comparator | Device: Conventional Programming (cDBS)This arm will include patients receiving stimulation with a conventional Deep Brain Stimulation (cDBS) for Parkinson's Disease (PD). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subject with PD implanted bilaterally in the STN and receiving DBS therapy for at least 3 months.
- Tolerates > 12 hours OFF medication and, per clinical judgment, be able to perform all study related procedures.
- Able to understand the study requirements and the treatment procedures and must provide written informed consent before any study-specific tests or procedures are performed.
Key exclusion criteria (2 listed)
- Exhibits significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
- A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant
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 |
|---|---|---|
| Novel Programming (nDBS)The commercial CP installed with the investigational DBS programming software will be used to set up Novel Programming (nDBS) therapy on the IPG. | Device | Novel Deep Brain Stimulation (nDBS) program |
| Conventional Programming (cDBS)The commercial CP installed with commercial software will be used to set up standard cDBS therapy on the IPG. | Device | Conventional Deep Brain Stimulation (cDBS) program |
Primary outcome
Improvement in Quality of Life using new programming paradigm: PDQ-39
Time frame: approximately 4 weeks
Change in Parkinson's Disease Questionnaire (PDQ-39) summary index and sub-scores
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 11 Dec 2025.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Programming (nDBS) and Conventional Programming (cDBS) in people with Parkinson's Disease (PD), run by Boston Scientific Corporation at 2 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 3 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 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Improvement in Quality of Life using new programming paradigm: PDQ-39 (time frame: approximately 4 weeks). 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 11 Dec 2025.