Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location

Neuropathy Clinical Trial

— CAWSAN  

Official title:

Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05565469
• Other study ID #: B2432022000021
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 23, 2022
• Est. completion date: February 27, 2023

Study information

• Verified date: September 2022
• Source: Jessa Hospital
• Contact: Maarten Vanloon
• Phone: +32479545156
• Email: maarten_vanloon[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 27, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuropathy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 15 minutes after start of the intervention