RegistryNCT06030973
Opinions of Healthcare Providers About a European Neuromodulation Register
An observational study of Registry and Neuromodulation, run by Moens Maarten at 1 site in Germany.
Trial summary
The goal of this online survey is to gain further insights in the needs and burden for a European registry for neuromodulation, according to healthcare providers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Registry, Neuromodulation, Survey
- What is being tested?
- Filling in an online survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 31 Aug 2023to 2 Sep 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In this study male and female adults who are involved in the management of chronic pain and more specifically in neuromodulation for pain (including but not limited to anesthesiologists, neurosurgeons, nurses) will be eligible to complete the survey. The survey will be spread at the 3ʳᵈ Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg from 31/8/2023 to 2/9/2023.
Who may be able to join
- Male and female adults who are involved in the management of chronic pain and more specifically in neuromodulation for pain (including but not limited to anesthesiologists, neurosurgeons, nurses).
Who cannot join
- Not involved in management of chronic pain through neuromodulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opinions of Healthcare Providers About a European Neuromodulation Register: an Online Survey
The goal of this online survey is to gain further insights in the needs and burden for a European registry for neuromodulation, according to healthcare providers.
- Conditions
- Registry, Neuromodulation, Survey
- Being tested
- Filling in an online survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling in an online surveyBehavioural
Professionals are asked to complete questions regarding 1) the degree of current participation in a registry, 2) the need for a European registry, 3) the items that should be collected and 4) access to the European registry.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare professionals involved in neuromodulation | Not described Receives: Behavioral: Filling in an online survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare providers their current degree of participation in a registry for neuromodulation.
Degree of participation in a registry for neuromodulation (question).
Measured: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.
Healthcare providers their need for a European registry.
Underlying reasons on why a European registry is needed, or not needed (question).
Measured: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.
Items that should be included in a registry for neuromodulation, according to healthcare providers.
Items that should be collection within a registry, evaluated with a multiple choice question.
Measured: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.
Access regulations to European registry for neuromodulation, according to healthcare providers.
Access regulations, evaluated with a multiple choice question.
Measured: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start31 Aug 2023
- Primary completion2 Sep 2023 (estimated)
- Study completion2 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RegistryStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moens Maarten
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Responsible party
- Sponsor-investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030973
- Sponsor's protocol ID
- PROLOGUE
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opinions of Healthcare Providers About a European Neuromodulation Register: an Online Survey
- ClinicalTrials.gov ID
- NCT06030973
- Acronym / sponsor ID
- PROLOGUE
- Conditions
- Registry, Neuromodulation, Survey
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Moens MaartenUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 2 Sep 2023 (estimated)
- Study completion
- 2 Sep 2023 (estimated)
- First posted
- 11 Sep 2023 (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 goal of this online survey is to gain further insights in the needs and burden for a European registry for neuromodulation, according to healthcare providers.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare professionals involved in neuromodulation | – | Behavioral: Filling in an online survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this study male and female adults who are involved in the management of chronic pain and more specifically in neuromodulation for pain (including but not limited to anesthesiologists, neurosurgeons, nurses) will be eligible to complete the survey. The survey will be spread at the 3ʳᵈ Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg from 31/8/2023 to 2/9/2023.
Key inclusion criteria (1 listed)
- Male and female adults who are involved in the management of chronic pain and more specifically in neuromodulation for pain (including but not limited to anesthesiologists, neurosurgeons, nurses).
Key exclusion criteria (1 listed)
- Not involved in management of chronic pain through neuromodulation.
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 |
|---|---|---|
| Filling in an online surveyProfessionals are asked to complete questions regarding 1) the degree of current participation in a registry, 2) the need for a European registry, 3) the items that should be collected and 4) access to the European registry. | Behavioural | Healthcare professionals involved in neuromodulation |
Primary outcome
Healthcare providers their current degree of participation in a registry for neuromodulation.
Time frame: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.
Degree of participation in a registry for neuromodulation (question).
Healthcare providers their need for a European registry.
Time frame: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.
Underlying reasons on why a European registry is needed, or not needed (question).
Items that should be included in a registry for neuromodulation, according to healthcare providers.
Time frame: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.
Items that should be collection within a registry, evaluated with a multiple choice question.
Access regulations to European registry for neuromodulation, according to healthcare providers.
Time frame: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.
Access regulations, evaluated with a multiple choice question.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Registry and Neuromodulation, run by Moens Maarten at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maarten Moens (+3224775514, stimulusresearchgroup@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare providers their current degree of participation in a registry for neuromodulation. (time frame: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.). The study lists 4 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 11 Sep 2023.