17
Participants
Start Date
September 30, 2025
Primary Completion Date
May 31, 2027
Study Completion Date
September 30, 2027
Lead(s) and Implantable Pulse Generator implantation
8-contact lead(s) will be radiologically positioned within the spinal foramen under awake anesthesia in order to optimize paresthesia coverage. Awake anesthesia will allow patients to be tested during the surgery in order to determine the sweet spot and the optimal paresthesia coverage using the PREDI-P platform for a single lead. A trial phase will be performed for a period of 7 days in order to assess the benefits of stimulation according to the HAS (French Health Authority) guidelines. Subjects who succeed the lead trial will receive a permanent implant depending on the patient electrical consumption during the lead trial period or according to the implanter decision.
Poitiers University Hospital, Poitiers
Poitiers University Hospital
OTHER