Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation

Last updated: January 9, 2025
Sponsor: Karel Hanssens
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Oral Facial Pain

Neuropathy

Treatment

ECAP-controlled, closed-loop SCS

Clinical Study ID

NCT06775535
51773
CME AZ Delta
Belgium registration number
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is deemed a suitable candidate for SCS trial and permanent implant and hasbeen 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) atbaseline

  • Subject is ≥ 18 years old.

  • Subject is not pregnant or nursing.

  • Subject is willing and capable of giving informed consent.

Exclusion

Exclusion Criteria:

  • Subject currently has an active implantable device including pacemakers, spinal cordstimulator 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.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: ECAP-controlled, closed-loop SCS
Phase:
Study Start date:
August 02, 2023
Estimated Completion Date:
December 31, 2029

Study 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.

Connect with a study center

  • AZ Delta

    Roeselare, 8800
    Belgium

    Active - Recruiting

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