Tsunami DRG High Frequency Stimulation Study

A European, Prospective, Multi-Center, Double-Blind, Randomized, Controlled, Clinical Trial Investigating the Effects of High Frequency Wireless Spinal Cord Stimulation (SCS) Over Exiting Nerve Roots in the Treatment of Chronic Back Pain

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Back Pain; Chronic Back and Leg Pain
• Intervention / Treatment: Device: Spinal Cord Stimulator HF; Device: Spinal Cord Stimulator Sham

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 Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Roeselare, Belgium, 8800
    • AZ Delta
  • Antwerpen
    • Wilrijk, Antwerpen, Belgium, 2610
      • GZA Sint-Augustinus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• Subject is ≥ 18 years of age at time of informed consent;
• Subjects have been diagnosed with predominant, chronic, intractable back pain with a VAS > 50 mm (on a 100-mm scale);
• Subjects have been diagnosed with predominant, chronic, intractable back pain for at least 6 months before study participation;
• Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regiment;
• Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
• Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
• Subject is willing and able to operate the patient programmer, recharging equipment and has the ability to undergo study assessments and provide accurate responses;
• Based on the opinion of the implanter, subject is a good surgical candidate for the implant procedure;
• Subject is male or non-pregnant female;
• Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a clinical psychologist and principal investigator, using face-to-face encounters and the psychological testing described in the measures;
• Patient is capable of giving informed consent.

Exclusion criteria

• Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);
• Unresolved malignancies in the last six months;
• Subject has post-herpetic neuralgia (shingles);
• Subject has an active systemic infection or is immune-compromised;
• Based on the medical opinion of the Principal Investigator the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
• Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
• Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication;
• Bleeding complications or coagulopathy issues;
• Pregnant/lactating or not using adequate birth control;
• A life expectancy of less than one year;
• Any active implanted device whether turned off or on;
• A previous SCS experience;
• Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Frequency; Subjects receiving high frequency pulse rate treatment over T9 exiting nerve roots. Subjects and assessors blinded Randomization.	Device: Spinal Cord Stimulator HF; A needle and catheter is carefully inserted near your spinal column. The stimulator is then placed through the catheter close to your spinal column. The proximal end of the stimulator is then sutured underneath the skin of your back to the fascia to prevent migration.
Sham Comparator: 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	Device: Spinal Cord Stimulator Sham; A needle and catheter is carefully inserted near your spinal column. The stimulator is then placed through the catheter close to your spinal column. The proximal end of the stimulator is then sutured underneath the skin of your back to the fascia to prevent migration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate	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	1 month post-implant

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PGIC	Subject satisfaction with the therapy as measured by the Patient Global Impression of Change (PGIC)	1, 3, 6, 9, 12 and 36 months
EQ-5D-5L	Changes from baseline in quality of life	1, 3, 6, 9, 12 and 36 months
AE's	Incidence of device related adverse events	1, 3, 6, 9, 12 and 36 months
Opioid Pain Medication	Prescribed opioid pain medications	1, 3, 6, 9, 12 and 36 months
Non-opioid Pain Medication	Prescribed non-opioid pain medication	1, 3, 6, 9, 12 and 36 months

Collaborators and Investigators

• Sponsor: Stimwave Technologies
• Collaborators: AZ Delta; GZA Ziekenhuizen Campus Sint-Augustinus

Publications and helpful links

General Publications

• O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 30-004060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Publication, Study outcomes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes