Assessing nerve activation in spinal cord stimulation for chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows patients with chronic pain who are undergoing a trial phase for the Evoke spinal cord stimulator. It aims to evaluate how different stimulation settings influence nerve activation and the resulting sensations experienced by the patients. By monitoring these parameters, the study seeks to improve the understanding of closed-loop spinal cord stimulation therapy and its effectiveness in managing chronic pain.

Why it matters

Who can join: the full rules

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.

Where it's running

• AZ Delta
  Roeselare, Belgium Recruiting

Study contacts

• Principal investigator: Karel Hanssens — AZ Delta
• Study coordinator: Karel Hanssens, Dr.
• Email: ctc.pijn@azdelta.be
• Phone: 0032 51 23 69 12

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.