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
ID
Bron
Verkorte titel
Aandoening
FBSS
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Successful ECAP guided lead placement
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
Baseline, 3,6 and 12 months
Onderzoeksproduct en/of interventie
Radio Frequency
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9620 |
| Ander register | MEC-U : R19.052 |