Parkinson DiseaseNCT06553625
Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS
An observational study of Parkinson Disease and Dystonia, run by Boston Scientific Corporation at 4 sites in 2 countries.
Trial summary
The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Dystonia, Essential Tremor
- What is being tested?
- Radiofrequency Ablation
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 29 Jan 2024to Dec 2035
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients planned to receive treatment with a commercially approved Boston Scientific RF system to create lesions in the central nervous system (CNS) for use in functional neurosurgery.
Who may be able to join
- Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain or for CNS applications per local Directions for Use (DFU)
- Signed a valid, IRB/EC/REB-approved informed consent form
Who cannot join
- Meets any contraindications per locally applicable Directions for Use (DFU)
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Germany3 sites, 3 recruiting
- Recruiting
Uniklinik Köln
Cologne
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitaetsklinikum Dusseldorf
Düsseldorf
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitaetsklinikum Wuerzburg
Würzburg
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
United Kingdom1 site, 1 recruiting
- Recruiting
St. Georges Hospital
London
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
About this study
Official title: Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System
The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.
Read the detailed description
The objective of this study is to compile real-world outcomes of Boston Scientific Corporation commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.
- Conditions
- Parkinson Disease, Dystonia, Essential Tremor, Movement Disorders
- Being tested
- Radiofrequency Ablation
- Medical subject headings
- Parkinson Disease, Dystonia, Essential Tremor, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency AblationDevice
Radiofrequency Ablation used in the central nervous system (CNS) in functional neurosurgery
| Study group | Role | What they receive |
|---|---|---|
| Boston Scientific Radiofrequency Ablation Systems | Subjects treated with Boston Scientific commercially approved radiofrequency (RF) ablation systems in the central nervous system (CNS). Receives: Device: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient's quality of life (QoL) during the study as compared with baseline
Change in quality of life assessments during the study as compared with baseline
Measured: Up to 24-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start29 Jan 2024
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie M Bloom Lyons, M.A., Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553625
- Sponsor's protocol ID
- A4106
- Other IDs
- 92802182
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System
- ClinicalTrials.gov ID
- NCT06553625
- Acronym / sponsor ID
- A4106
- Conditions
- Parkinson Disease, Dystonia, Essential Tremor, Movement Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 14 Aug 2024 (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 objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.
Detailed description
The objective of this study is to compile real-world outcomes of Boston Scientific Corporation commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boston Scientific Radiofrequency Ablation Systems | – | Device: Radiofrequency AblationSubjects treated with Boston Scientific commercially approved radiofrequency (RF) ablation systems in the central nervous system (CNS). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients planned to receive treatment with a commercially approved Boston Scientific RF system to create lesions in the central nervous system (CNS) for use in functional neurosurgery.
Key inclusion criteria (2 listed)
- Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain or for CNS applications per local Directions for Use (DFU)
- Signed a valid, IRB/EC/REB-approved informed consent form
Key exclusion criteria (2 listed)
- Meets any contraindications per locally applicable Directions for Use (DFU)
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
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 |
|---|---|---|
| Radiofrequency AblationRadiofrequency Ablation used in the central nervous system (CNS) in functional neurosurgery | Device | Boston Scientific Radiofrequency Ablation Systems |
Primary outcome
Change in patient's quality of life (QoL) during the study as compared with baseline
Time frame: Up to 24-Months
Change in quality of life assessments during the study as compared with baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Related trials for Parkinson Disease
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
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.
Natalie M Bloom Lyons, M.A. study director
Boston Scientific Corporation
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Dystonia, run by Boston Scientific Corporation at 4 sites in 2 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 2 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: looking for participants now, as of the sponsor's last update on 13 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 4 sites in Germany, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Delvaux (855-213-9890, BSNClinicalTrials@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient's quality of life (QoL) during the study as compared with baseline (time frame: Up to 24-Months). 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 13 Oct 2026.