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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 PainNeuropathic PainPersistent 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

Locations(1)

AZ Delta

Roeselare, Belgium

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NCT06775535

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