NCT02787252

Stimwave HF SCS Pilot Study

Prospective, Clinical Pilot Study of High Frequency Wireless Spinal Cord Stimulation (SCS) in the Treatment of Chronic Pain With The Freedom Spinal Cord Stimulatory

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Curonix LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe the efficacy of stimulation on over all pain relief as reported in an initial cohort of 6 patients treated with the Freedom High Frequency Spinal Cord Stimulator (SCS) System for low back and/or leg pain.

Detailed description

This is a non-blinded, short-term study for a maximum duration of 12 weeks in which 6 patients will receive a Freedom SCS System. Subjects will have chronic, intractable pain of the trunk and/or lower limbs refractory to standard medical treatment; including unilateral or bilateral pain. Stimulators will be placed in the epidural space and over exiting nerve roots at vertebrae levels: A. Bilateral T9-T10 epidural; B. Bilateral L1-L4 epidural. All Patients will be treated below perception threshold with High Frequency settings (10.000 Hz, 30 μs).

Conditions

• FBSS

Interventions

Type	Name	Description
DEVICE	Implant procedure, Freedom Spinal Cord Stimulation System	A needle is carefully inserted near the spinal cord. The stimulator is then slide through the needle to lay close to the spinal cord. The end of the stimulator is then sutured underneath the skin of the back.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-06-01
• Last updated: 2017-06-08

Locations

1 site across 1 country: Belgium