115
Participants
Start Date
July 24, 2020
Primary Completion Date
May 9, 2022
Study Completion Date
October 17, 2023
DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system
Along with the appropriate Conventional Medical Management treatment made by the Investigator, the subject will be trialed and implanted with an Intellis™ neurostimulator system using DTM™ SCS programming parameters.
Conventional Medical Management (CMM)
The CMM treatment can be modified at any moment by the investigators based on their clinical evaluation and local standard of care. They may also consists of one or more of the following treatments: medications, combined physical and psychological management, physical therapy, back rehabilitation program, spinal manipulation and spinal mobilization, traction, acupuncture, cognitive behavioral therapy, biofeedback, nerve blocks, radio frequency ablation, epidural steroid injections, transcutaneous electrical nerve stimulation, intradiscal electrothermal therapy, nucleoplasty, also called plasma disc decompression (PDD) or similar
AZ Delta, Roeselare
AZ Nikolaas, Sint-Niklaas
GZA - Sint Augustinus Ziekenhuis, Wilrijk
Universitätsklinikum Düsseldorf, Düsseldorf
München Klinik Bogenhausen, München
Rijnstate - Locatie Elst, Elst
Maastricht University Medical Center, Maastricht
Diakonessenhuis Locatie Zeist, Zeist
Hospital Clínico Universitario de Santiago, A Coruña
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda
Hospital Universitario Virgen del Rocío, Seville
Hospital Clínico Universitario de Valencia, Valencia
Lead Sponsor
SGX Group
INDUSTRY
MedtronicNeuro
INDUSTRY