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

Jessa Hospital

Status: Not yet enrolling

Conditions: Neurostimulator; Complication; Neuropathy

Treatments: Other: Adjustment of neurostimulator settings

Study type: Interventional

Funder types: Other

Identifiers

NCT05565469

B2432022000021

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Neurostimulator group

Experimental group

Description:

Adjustment of neurostimulator settings to see whether or not abdominal stimulation can be provoked

Treatment:

Other: Adjustment of neurostimulator settings