NCT03543085

Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain

A Single-arm, Open Label, Single Center, Prospective Study of Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: GiMer Medical · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultra-high frequency (500 KHz) spinal cord stimulation in patients with chronic back pain or lower limb pain.

Detailed description

This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultra-high frequency (500 KHz) spinal cord stimulation in patients with chronic back pain or lower limb pain. The trial length is 14 days. Patients will be given ultrahigh frequency pulse stimulation, up to 3 times in every 24 hours, and VAS will be obtained at least once a day. Compared to previous study conducted last year, patient can now have two lead implant sites for different pain locations. The electrode implantation site will be epidural space instead of Dorsal Root Ganglion (DRG).

Conditions

• Pain, Chronic
• Pain, Back
• Pain, Radiating

Interventions

Type	Name	Description
DEVICE	GiMer Medical MN 1000 External Stimulator	Trial stimulator (GiMer Medical Model 1000 External Stimulator) to generate pulsed ultrahigh frequency (\>200KHz) electrical stimulation, delivered via lead in epidural space, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.

Timeline

• Start date: 2018-04-12
• Primary completion: 2018-10-23
• Completion: 2018-10-23
• First posted: 2018-06-01
• Last updated: 2021-10-13
• Results posted: 2021-10-13

Locations

1 site across 1 country: Taiwan