Neurostimulator; ComplicationCAWSANNCT05565469
Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location
A study testing Adjustment of neurostimulator settings in people with Neurostimulator; Complication and Neuropathy, run by Jessa Hospital.
Trial summary
In this prospective interventional study, we look at the level of tip of the DTM neurostimulator and the presence of abdominal wall stimulation in patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurostimulator; Complication, Neuropathy
- What is being tested?
- Adjustment of neurostimulator settings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2022to 27 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a DTM neurostimulator for Failed Back Surgery Syndrome (FBSS) at the thoracic level
Who cannot join
- Patients younger than 18 years of age
- Patients who are not able to exercise their will.
- Inability to understand the Dutch language
Trial locations and contacts
No sites are listed yet.
Mark Plazier, dr. contact
About this study
In this prospective interventional study, we look at the level of tip of the DTM neurostimulator and the presence of abdominal wall stimulation in patients
- Conditions
- Neurostimulator; Complication, Neuropathy
- Being tested
- Adjustment of neurostimulator settings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustment of neurostimulator settingsOther
This is an interventional prospective study. After obtaining informed consent, only necessary information will be extracted through the electronic patient record. Through post-operative imaging, a level determination of the neurostimulator tip will be done. During general consultations, patients will be asked if they experienced abdominal wall stimulation after the procedure and when (YES/NO, NRS). This will include looking at the settings of the neurostimulator. And its adjustments. Furthermore, general epidemiological characteristics such as age, gender, height, weight will be extracted from the electronic patient record.
At the consultation, another active programming will take place (in accordance with clinical programming) on the tip of the electrode to check whether it provokes abdominal wall stimulation. This will also be scored YES/NO + NRS. Then the settings will be returned as they were pre-consultation.
| Study group | Role | What they receive |
|---|---|---|
| Neurostimulator group | Experimental | Adjustment of neurostimulator settings to see whether or not abdominal stimulation can be provoked Receives: Other: Adjustment of neurostimulator settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal stimulation
Is abdominal wall stimulation present YES/NO and if so what is the score between 0 and 10 on an NRS 1-10. This is then correlated to the position of the electrode.
Measured: up to 15 minutes after start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start23 Sep 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion27 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurostimulator; ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Plazier, dr., Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565469
- Sponsor's protocol ID
- B2432022000021
- Acronym
- CAWSAN
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vanloon M, Raymaekers V, Meeuws S, de Ridder D, Plazier M. Correlation Between Abdominal Wall Stimulation and Spinal Cord Stimulator Tip Location: A Nonrandomized Clinical Trial. Neuromodulation. 2023 Oct;26(7):1459-1464. doi: 10.1016/j.neurom.2023.07.004. Epub 2023 Aug 23.
PubMed 37632515
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location
- ClinicalTrials.gov ID
- NCT05565469
- Acronym / sponsor ID
- CAWSAN / B2432022000021
- Conditions
- Neurostimulator; Complication, Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 23 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 27 Feb 2023 (estimated)
- First posted
- 4 Oct 2022 (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.
In this prospective interventional study, we look at the level of tip of the DTM neurostimulator and the presence of abdominal wall stimulation in patients
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurostimulator group | Experimental | Other: Adjustment of neurostimulator settingsAdjustment of neurostimulator settings to see whether or not abdominal stimulation can be provoked |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a DTM neurostimulator for Failed Back Surgery Syndrome (FBSS) at the thoracic level
Key exclusion criteria (3 listed)
- Patients younger than 18 years of age
- Patients who are not able to exercise their will.
- Inability to understand the Dutch language
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 |
|---|---|---|
| Adjustment of neurostimulator settingsThis is an interventional prospective study. After obtaining informed consent, only necessary information will be extracted through the electronic patient record. Through post-operative imaging, a level determination of the neurostimulator tip will be done. During general consultations, patients will be asked if they experienced abdominal wall stimulation after the procedure and when (YES/NO, NRS). This will include looking at the settings of the neurostimulator. And its adjustments. Furthermore, general epidemiological characteristics such as age, gender, height, weight will be extracted from the electronic patient record. At the consultation, another active programming will take place (in accordance with clinical programming) on the tip of the electrode to check whether it provokes abdominal wall stimulation. This will also be scored YES/NO + NRS. Then the settings will be returned as they were pre-consultation. | Other | Neurostimulator group |
Primary outcome
Abdominal stimulation
Time frame: up to 15 minutes after start of the intervention
Is abdominal wall stimulation present YES/NO and if so what is the score between 0 and 10 on an NRS 1-10. This is then correlated to the position of the electrode.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Derived from this study: PubMed 37632515Vanloon M, Raymaekers V, Meeuws S, de Ridder D, Plazier M. Correlation Between Abdominal Wall Stimulation and Spinal Cord Stimulator Tip Location: A Nonrandomized Clinical Trial. Neuromodulation. 2023 Oct;26(7):1459-1464. doi: 10.1016/j.neurom.2023.07.004. Epub 2023 Aug 23.
- Individual participant dataSharing planned: Undecided
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.
Mark Plazier, dr. contact
Mark Plazier, dr. principal investigator
Jessa Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Adjustment of neurostimulator settings in people with Neurostimulator; Complication and Neuropathy, run by Jessa Hospital.
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 3 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 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Vanloon (+32479545156, maarten_vanloon@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal stimulation (time frame: up to 15 minutes after start of the intervention). 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 NCT05565469, which also lists 1 linked publication.
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 4 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.