Peripheral Neuropathy
Conditions
Keywords
PNP, Stimulation, Peripheral neurostimulation
Brief summary
The current study will evaluate the safety and performance of the BlueWind Medical Reprieve System for the treatment of Chronic Painful Peripheral Neuropathy.
Detailed description
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
1. Signed written informed consent. 2. Male or female aged 18 - 80. 3. Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out pain questionnaires. 4. Diagnosis of chronic neuropathic pain due to peripheral neuropathy. 5. Documented pain attributed to neuropathy for at least 6 months. 6. Pain intensity with an average daily VAS score of at least 6, demonstrated by 2-3 ratings per day across 7 days. 7. Patient refractory to conservative treatments including pain medication, for at least 6 months. 8. Stable pain medication for at least 4 weeks prior to study enrollment.
Exclusion criteria
1. Previous participation in another study with any investigational drug or device within the past 90 days. 2. Any active implant (cardiac or other). 3. Any metal implant in the area of BlueWind device implantation site. 4. Current pregnancy or attempting to get pregnant (female patient). 5. Any clinically significant neurologic disorders (except PNP). 6. Any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study. 7. Patients with severe or unstable cardiovascular, pulmonary, gastrointestinal, hematological, hepatic, renal or endocrine diseases. 8. Severe peripheral vascular disease that may cause intermittent claudication or ischemic ulcers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs). | 6 months | The incidence of system and/or procedure related serious adverse events (SAEs) throughout the entire study period |
| Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation | 1 Month, 3 Months, and 6 months post system activation | VAS score assessment at baseline and follow up visits was performed in two ways; 1. Pain Diary VAS score- the analysis was based on the pain diary, processing the average daily VAS scores over seven consecutive days. 2. Point VAS score- the analysis was based on the VAS score measurement recorded during the baseline visit and following 30 minutes stimulation at all follow up visits.Pain assessment by Visual Analogue Scale (VAS) as compared to baseline, post system activation. Visual Analogue Scale (VAS) for Pain Scores on a scale \[0 - 10\], higher values represent a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success 6 Months Post Activation | 1 Month, 3 Months, and 6 months post system activation | Clinical success at 6 months post activation was further assessed by:Short-form McGill pain questionnaire. McGill pain questionnaire Scores on a scale Range \[0-60\] points, higher values represent a worse outcome. |
Countries
Belgium, Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| The Reprieve System Implantation The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations.
The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Implant removal | 1 |
Baseline characteristics
| Characteristic | The Reprieve System Implantation |
|---|---|
| Age, Continuous | 59.7 years |
| pain measurement using Visual Analogue Scale | 7.58 units on a scale STANDARD_DEVIATION 1.11 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 4 / 13 |
| serious Total, serious adverse events | 1 / 13 |
Outcome results
Primary
Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation
VAS score assessment at baseline and follow up visits was performed in two ways; 1. Pain Diary VAS score- the analysis was based on the pain diary, processing the average daily VAS scores over seven consecutive days. 2. Point VAS score- the analysis was based on the VAS score measurement recorded during the baseline visit and following 30 minutes stimulation at all follow up visits.Pain assessment by Visual Analogue Scale (VAS) as compared to baseline, post system activation. Visual Analogue Scale (VAS) for Pain Scores on a scale \[0 - 10\], higher values represent a worse outcome.
Time frame: 1 Month, 3 Months, and 6 months post system activation
Population: Out of the 13 treated patients, one device was explanted approximately after 3 weeks of treatment. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Reprieve System Implantation | Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation | Pain Diary VAS Score - 1M post system activation | 3.94 score on a scale | Standard Deviation 1.67 |
| The Reprieve System Implantation | Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation | Pain Diary VAS score - 3M post system activation | 3.75 score on a scale | Standard Deviation 1.67 |
| The Reprieve System Implantation | Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation | Pain Diary VAS Score - 6M post system activation | 3.14 score on a scale | Standard Deviation 1.52 |
| The Reprieve System Implantation | Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation | Point VAS Score - 1M post system activation | 3.38 score on a scale | Standard Deviation 2.48 |
| The Reprieve System Implantation | Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation | Point VAS score - 3M post system activation | 2.79 score on a scale | Standard Deviation 2.4 |
| The Reprieve System Implantation | Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation | Point VAS Score - 6M post system activation | 2.42 score on a scale | Standard Deviation 2.61 |
Primary
The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs).
The incidence of system and/or procedure related serious adverse events (SAEs) throughout the entire study period
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Reprieve System Implantation | The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs). | 1 Participants |
Secondary
Clinical Success 6 Months Post Activation
Clinical success at 6 months post activation was further assessed by:Short-form McGill pain questionnaire. McGill pain questionnaire Scores on a scale Range \[0-60\] points, higher values represent a worse outcome.
Time frame: 1 Month, 3 Months, and 6 months post system activation
Population: Only 12 out of 13 patients completed the study. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Reprieve System Implantation | Clinical Success 6 Months Post Activation | McGill pain questionnaire - 1M post sys activation | 14 score on a scale | Standard Deviation 12.1 |
| The Reprieve System Implantation | Clinical Success 6 Months Post Activation | McGill pain questionnaire - 3M post sys activation | 13.5 score on a scale | Standard Deviation 13.4 |
| The Reprieve System Implantation | Clinical Success 6 Months Post Activation | McGill pain questionnaire - 6M post sys activation | 12.3 score on a scale | Standard Deviation 14.3 |
Secondary
Clinical Success 6 Months Post Activation
Clinical success is defined as the effect of the BlueWind Reprieve System on the treatment of the following symptoms compared to baseline: \- Pain related medication consumption/day
Time frame: 6 months post activation
Population: Only 12 out of 13 patients completed the study. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The Reprieve System Implantation | Clinical Success 6 Months Post Activation | not consumed any pain related medication | 1 Participants |
| The Reprieve System Implantation | Clinical Success 6 Months Post Activation | didn't change medication consumption | 5 Participants |
| The Reprieve System Implantation | Clinical Success 6 Months Post Activation | Reduction in medication consumption | 6 Participants |
Secondary
Clinical Success 6 Months Post Activation
Clinical success was further assessed by: Quality of life questionnaire (SF-36 Health Survey) SF-36 Health Survey Scores on a scale \[0 - 100\], higher values represent a better outcome.
Time frame: 1 Month, 3 Months, and 6 months post system activation
Population: Only 12 out of 13 patients completed the study. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Reprieve System Implantation | Clinical Success 6 Months Post Activation | SF-36 Health Survey - 1M post system activation | 65.6 score on a scale | Standard Error 5.2 |
| The Reprieve System Implantation | Clinical Success 6 Months Post Activation | SF-36 Health Survey - 3M post system activation | 66.4 score on a scale | Standard Error 5 |
| The Reprieve System Implantation | Clinical Success 6 Months Post Activation | SF-36 Health Survey - 6M post system activation | 66.9 score on a scale | Standard Error 4.2 |