Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location (CAWSAN)

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 Overview

• Status: Not yet recruiting
• Conditions: Neuropathy; Neurostimulator; Complication
• Intervention / Treatment: Other: Adjustment of neurostimulator settings

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maarten Vanloon; Phone Number: +32479545156; Email: maarten_vanloon@hotmail.com
• Study Contact Backup: Name: Mark Plazier, dr.; Email: mark.plazier@jessazh.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neurostimulator group; Adjustment of neurostimulator settings to see whether or not abdominal stimulation can be provoked

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Investigators: Principal Investigator: Mark Plazier, dr., Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 23, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): February 27, 2023

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: B2432022000021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No