NCT05565469

Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jessa Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neurostimulator; Complication
• Neuropathy

Interventions

Type	Name	Description
OTHER	Adjustment 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.

Timeline

• Start date: 2022-09-23
• Primary completion: 2022-12-31
• Completion: 2023-02-27
• First posted: 2022-10-04
• Last updated: 2022-10-04