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Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location

Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05565469
Acronym
CAWSAN
Enrollment
30
Registered
2022-10-04
Start date
2022-09-23
Completion date
2023-02-27
Last updated
2022-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathy, Neurostimulator; Complication

Brief 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

Interventions

OTHERAdjustment of neurostimulator settings

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.

Sponsors

Jessa Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with a DTM neurostimulator for Failed Back Surgery Syndrome (FBSS) at the thoracic level

Exclusion criteria

* Patients younger than 18 years of age * Patients who are not able to exercise their will. * Inability to understand the Dutch language

Design outcomes

Primary

MeasureTime frameDescription
Abdominal stimulationup to 15 minutes after start of the interventionIs 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.

Contacts

Primary ContactMaarten Vanloon
maarten_vanloon@hotmail.com+32479545156
Backup ContactMark Plazier, dr.
mark.plazier@jessazh.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026