Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation (NAA)

Karel Hanssens

Status: Enrolling

Conditions: Neuropathic Pain; Chronic Pain; Persistent Spinal Pain Syndrome Type 2

Treatments: Device: ECAP-controlled, closed-loop SCS

Study type: Observational

Funder types: Other

Identifiers

NCT06775535

51773

Belgium registration number (Other Identifier)

CME AZ Delta (Other Identifier)

Details and patient eligibility

About

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

Full description

The study follow patients with chronic pain who received an EvokeTM spinal cord stimulator. The main aim of this study is to evaluate what influence different settings on nerve activation have and how this affects patients' sensation.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.