Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Patients with Cervical Lead Placement
Launched by RIJNSTATE HOSPITAL · Apr 8, 2024
Trial Information
Current as of July 24, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Title Assessment of effectiveness and stimulation coverage of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with cervical lead placement.
Device used in the study The Saluda Medical EvokeTM Closed-Loop Spinal Cord Stimulator (CL-SCS) System (Evoke System). The CE marked Evoke System will be used within its licensed use and manuals. The Evoke System measures and records spinal cord (SC) activation resulting from stimulation via evoked compound action potentials (ECAPs). The Evoke System can be programmed to provide ECAP-controlled, closed-loop SCS or open-loop, fixed-outp...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Subject is deemed a suitable candidate for SCS trail and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.
- • 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.
About Rijnstate Hospital
Rijnstate Hospital is a leading healthcare institution based in the Netherlands, dedicated to providing high-quality patient care and advancing medical research. With a strong emphasis on innovation and collaboration, Rijnstate Hospital actively engages in clinical trials to explore new treatment options and improve patient outcomes across various medical fields. The hospital's multidisciplinary approach integrates the expertise of healthcare professionals, researchers, and academic partners, ensuring rigorous scientific methodologies and adherence to ethical standards. Committed to enhancing the health and well-being of the communities it serves, Rijnstate Hospital plays a pivotal role in the advancement of medical knowledge and the development of effective therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Arnhem, Gelderland, Netherlands
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported