RecruitingNCT06775535

Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation

Assessment of Neuronal Activation Accuracy and Stimulation Sensation in Patients with Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy

Sponsor

Karel Hanssens

Enrollment

12 participants

Start Date

Aug 2, 2023

Study Type

OBSERVATIONAL

Conditions

Chronic Pain Neuropathic Pain Persistent Spinal Pain Syndrome Type 2

Summary

Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria3

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.

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Interventions

DEVICEECAP-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