Chronic PainNeuropathic PainPersistent Spinal Pain Syndrome Type 2
Investigational drug(s) / intervention(s)
ECAP-controlled, closed-loop SCS
ECAP-controlled, closed-loop SCS: Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Study summary
Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
* Subject is willing and capable of giving informed consent.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Number of participants with change in stimulation sensation — 6-months Stimulation sensation will be characterized by study participants as better, worse or same for 5 different closed-loop sensitivity settings.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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