Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarel Hanssens
About this trial
Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.
Eligibility criteria
Qualifiers
Subject is deemed a suitable candidate for SCS trial and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.
Subject has a minimum of pain intensity of 5/10 on the numeric rating scale (NRS) at baseline
Subject is ≥ 18 years old.
Subject is not pregnant or nursing.
Disqualifiers
Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.
Subject is incapable of understanding or responding to the study questionnaires.
Subject is incapable of understanding or operating the patient programmer handset.
Trial design
Treatments tested in this trial
- ECAP-controlled, closed-loop SCS
Treatment groups
No treatment groups listed
Sponsors and collaborators
Karel Hanssens
Lead sponsor
AZ Delta
Sponsor institution
Source ClinicalTrials.gov