CAWSAN: Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location
Sponsor
Jessa Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05565469
Collaborator
(none)
30
1
5.2
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location
Anticipated Study Start Date
:
Sep 23, 2022
Anticipated Primary Completion Date
:
Dec 31, 2022
Anticipated Study Completion Date
:
Feb 27, 2023
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Abdominal stimulation [up to 15 minutes after start of the intervention]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jessa Hospital
Investigators
- Principal Investigator: Mark Plazier, dr., Jessa Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Jessa Hospital
ClinicalTrials.gov Identifier:
NCT05565469
Other Study ID Numbers:
- B2432022000021
First Posted:
Oct 4, 2022
Last Update Posted:
Oct 4, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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