Study of Spinal Transforaminal NeuroStimulation Using FAST and MULTIWAVE to Treat Refractory Chronic Neuropathic Pain in Adults

What this Trial Is About

Researchers are evaluating Spinal Transforaminal NeuroStimulation STNS using FAST and MULTIWAVE stimulation to relieve neuropathic peripheral pain in people with chronic neuropathic pain. The study aims to demonstrate the effectiveness of these low-risk, low-energy treatments in patients who have not found relief with other methods. Participants will have one or two 8-contact leads placed near the spinal foramen under awake anesthesia to optimize nerve coverage. After this, they will undergo a 7-day trial phase to assess pain relief. Those with at least a 30% reduction in leg pain during this phase will receive a permanent implantable pulse generator. Initially, all patients will use FAST stimulation for at least 24 hours, and if unsatisfied, they may switch to other programmed waveforms including conventional and microburst stimulation. During the study, participants will be monitored for changes in pain intensity, health-related quality of life, functional ability, anxiety, depression, and patient satisfaction at 1, 3, and 6 months after implantation. Researchers will also evaluate neural targeting with imaging and electrophysiological tests and track any device-related events. The primary outcome is the change in the Multidimensional Clinical Response Index at 6 months.

Evaluation of the Efficacy of STNS With FAST and MULTIWAVE in Patients With Refractory Chronic Neuropathic Pain