Peripheral Neuropathic Pain
Conditions
Keywords
Peripheral Neuropathic Pain, PNP
Brief summary
The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external components. The system is intended for home care use. The chronic pain treatment is achieved by an electrical stimulation of peripheral nerve fibers. The stimulation is set so that it generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and improving the quality of life for the patient.
Interventions
DEVICEThe Reprieve system
BlueWind Medical neurostimulator for the treatment of neuropathic pain
Sponsors
BlueWind Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent. * Male or female aged 18 - 80. * Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out pain questionnaires. * Diagnosis of chronic neuropathic pain due to peripheral neuropathy. * Documented pain attributed to neuropathy for at least 6 months. * Pain intensity with an average daily VAS score of at least 6, demonstrated by 3 ratings per day across 7 days. * Patient refractory to conservative treatments including pain medication, for at least 6 months. * Stable pain medication for at least 4 weeks prior to study enrollment.
Exclusion criteria
* Previous participation in another study with any investigational drug or device within the past 90 days. * Any active implant (cardiac or other). * Any metal implant in the area of BlueWind device implantation site. * Current pregnancy or attempting to get pregnant (female patient). * Any clinically significant neurologic disorders (except PNP).- Any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study. * Patients with severe or unstable cardiovascular, pulmonary, gastrointestinal, hematological, hepatic, renal or endocrine diseases. * Severe peripheral vascular disease that may cause intermittent claudication or ischemic ulcers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of serious adverse events | 6 months | The incidence of serious adverse events (system and/or procedure related events) |
| Pain assessment | 6 months post system activation | Pain assessment by Visual Analogue Scale (VAS) as compared to baseline at 6 months post activation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success defined as the effect of the Reprieve System on patient's symptoms | 6 months post system activation | Measurements include: SF-McGill pain Questionnaire Pain related medication consumption/day Quality of life questionnaire SF-36 Health survey and safety |
Countries
Israel
Outcome results
None listed