NCT06775535 Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation
| NCT ID | NCT06775535 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karel Hanssens |
| Condition | Chronic Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-08-02 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 12 participants in total. It began in 2023-08-02 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Karel Hanssens
PRINCIPAL INVESTIGATOR
AZ Delta
Frequently Asked Questions
Who can join the NCT06775535 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06775535 currently recruiting?
Yes, NCT06775535 is actively recruiting participants. Contact the research team at ctc.pijn@azdelta.be for enrollment information.
Where is the NCT06775535 trial being conducted?
This trial is being conducted at Roeselare, Belgium.
Who is sponsoring the NCT06775535 clinical trial?
NCT06775535 is sponsored by Karel Hanssens. The principal investigator is Karel Hanssens at AZ Delta. The trial plans to enroll 12 participants.
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