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This study is a prospective, multi-site, randomized, shamcontrolled, double-blind trial with one-way crossover designed to assess the effectiveness and safety of the Gimer NeuroBlock SCS Trialing System for the treatment of chronic back pain and/or lower limb pain. The NeuroBlock SCS Trialing System is an ultra-high frequency SCS device for the treatment of patients with chronic back pain and/or lower limb pain who are refractory to conservative pain management. After screening procedures, eligible subjects will enter the study which is comprised of a 1-week randomized testing period, a 1-week follow-up period and 2-week observation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group- UHF(+RF) stimulation | Experimental | Patients implanted with leads and be administered with UHF stimulation |
|
| Control group | No Intervention | Patients implanted with lead receiving fake stimulation (no stimulation but same device procedure with test group) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroBlock UHF stimulation | Device | NeuroBlock ultrahigh frequency (UHF) stimulation with 500kHz intra-pulse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: Responder Rate | The responder rate of the test group and control group at the 2-week visit | 2 weeks |
| Safety: AEs and SAEs | Incidence of adverse events (AEs) and serious AEs (SAEs) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Subject has the following conditions by investigator's discretion at screening visit or during the last 3 months:
Subject has exhibited unstable pain condition within the past 28 days as interviewed by Investigator.
Subject has a currently diagnosed coagulation disorder, bleeding diathesis, progressive peripheral vascular disease with PLT < 100,000/μl or INR > 1.4 at screening visit.
Subject has unstable pain medication(s) for at least 28 days at investigator's discretion.
Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy.
Subject has a current diagnosis of cancer with active symptoms.
Subject has a known terminal illness with life expectancy less than one year.
Subject has a systematic or local infection, which may increase study risk.
Subject currently has an indwelling device that may pose an increased risk of infection.
Subject is pregnant or breast feeding.
Subject has a medical history of drug or alcohol addiction within the past 2 years.
Subject has participation in any investigational study in the last 30 days or current enrollment in any trial.
Subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation.
Subject is a prisoner.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | Taiwan | ||||
| Mackay Memorial Hospital |
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| Taipei |
| Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Veterans General Hospital-Taipei | Taipei | Taiwan |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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