No registrations found.
ID
Source
Brief title
Health condition
FBSS
Sponsors and support
Intervention
Outcome measures
Primary outcome
Successful ECAP guided lead placement
Secondary outcome
1. Neurophysiological characterisations and patient reported outcomes
Background summary
The positioning of Spinal Cord Stimulation (SCS) leads in the epidural space to deliver therapy for chronic pain currently relies on intra-operative feedback from the patient during the procedure. This feedback is not always very reliable due to sedation, discomfort and peculiar positioning (prone) of the patient on the operating table. By utilising the recording capabilities of a new type of SCS system it may be possible to use objective neurophysiological signals to optimally place leads.
Study objective
This could potentially improve the speed and accuracy of the operation to implant the epidural leads and make the procedure more comfortable for the patient
Study design
Baseline, 3,6 and 12 months
Intervention
Radio Frequency
Inclusion criteria
1. Patient has been included for implantation according to standard criteria from the Dutch Neuromodulation Society.
2. Chronic refractory pain as a result of post-laminectomy syndrome (FBSS) for at least 6 months.
3. Patient is >18 years old.
4. Patient is able and willing to comply with the protocol and follow-up.
5. Patient is fluent in the Dutch language.
6. Patient is able to provide written informed consent.
Exclusion criteria
1. Patient is under 18 years old
2. Patient is pregnant or nursing
3. Patient is unable to operate the EvokeTM SCS System
4. Patient is an unsuitable candidate for SCS
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9620 |
| Other | MEC-U : R19.052 |