Assessing nerve activation in spinal cord stimulation for chronic pain
Assessment of Neuronal Activation Accuracy and Stimulation Sensation in Patients with Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy
This study looks at how different settings on a spinal cord stimulator affect nerve activity and sensations in patients with chronic pain to help improve pain management.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AZ Delta Academic / other |
| Locations | 1 site (Roeselare) |
| Trial ID | NCT06775535 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic pain rated at least 5/10 on a numeric scale who are suitable for spinal cord stimulation.
Not a fit: Patients with active implantable devices or those unable to understand the study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of spinal cord stimulation therapy for chronic pain patients.
How similar studies have performed: While similar studies have explored spinal cord stimulation, this specific approach focusing on neuronal activation accuracy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Roeselare
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.