RecruitingNot Applicable

Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation

Belgium12 participantsStarted 2023-08-02

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with change in stimulation sensation

Timeframe: 6-months

Trial details

NCT IDNCT06775535

SponsorKarel Hanssens

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-08

Contact for this trial

Karel Hanssens, Dr.

0032 51 23 69 12 ctc.pijn@azdelta.be

View on ClinicalTrials.gov More Chronic Pain trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.