Tsunami DRG High Frequency Stimulation Study

Not Applicable

Active, not recruiting

• Conditions: Chronic Back Pain; Chronic Back and Leg Pain
• Interventions: Device: Spinal Cord Stimulator HF; Device: Spinal Cord Stimulator Sham

• Registration Number: NCT03312010
• Lead Sponsor: Curonix LLC

Brief Summary

Prospective, double blinded, randomized, clinical study investigating the effects of high frequency SCS over exiting nerve roots at T9 for the treatment of chronic back or back and leg pain.

Detailed Description

All subjects will have two permanent stimulators placed over the exiting nerve roots at T9 at the implant visit. The stimulators can easily be removed for non-responders. High frequency stimulation is typically programmed below sensory threshold. This type of stimulation lends itself to a placebo-controlled trial. For this study subjects will be randomized 1:1 at enrollment into a high frequency or sham group. Neither the subjects nor experimenters will be made aware of their randomization assignment for at least the first month of the trial. Subjects belonging to both groups will be unblinded to their assignment at the 1-month or a later visit (including unscheduled visit) if they have a VAS \> 30 mms. Subjects belonging to the sham group will be reprogrammed with HF stimulation at this point. Subjects belonging to the HF stimulation group will keep stimulating with HF. Subjects reporting a VAS \< 30 mms will continue to be blinded.

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-17
• Study Start: 2018-03-01
• Primary Completion: 2019-08-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Frequency	Spinal Cord Stimulator HF	Subjects receiving high frequency pulse rate treatment over T9 exiting nerve roots. Subjects and assessors blinded Randomization.
Sham	Spinal Cord Stimulator Sham	Subjects receiving Sham (non-active) treatment over T9 exiting nerve roots. Subjects and assessors blinded to randomization. Subjects and assessors to be unblinded if pain scores are 30 mms or higher with VAS after 1-month follow-up. Upon this moment subjects to receive active stimulation

Primary Outcome Measures

Name	Time	Method
Responder rate	1 month post-implant	a \> 50% reduction in back pain as measured by VAS with the Freedom SCS system in the HF (test) group as opposed to sham and conventional medical management

Secondary Outcome Measures

Name	Time	Method
VAS leg pain	1, 3, 6, 9, 12 and 36 months	Percentage change from baseline in VAS for leg pain
VAS back pain	1, 3, 6, 9, 12 and 36 months	Percentage change from baseline in VAS for back pain
ODI	1, 3, 6, 9, 12 and 36 months	Change from baseline in functionality using the ODI score

Trial Locations

Locations (2)

GZA Sint-Augustinus; 🇧🇪 Wilrijk, Antwerpen, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium