Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being done to see how well a new investigational medical device, the StimRouter (STR) System, will work to treat the chronic pain in people who have failed previous treatments for Carpal Tunnel Syndrome (CTS) pain, including surgery. These people have been treated for CTS pain before including surgical carpal tunnel release, but without good results, and they are still having pain. The study will look at both the good and bad effects of the StimRouter System for treating this kind of pain and as a general peripheral nerve stimulation device for treating chronic pain. The study will also help to understand other possible uses for the StimRouter System.
This is a prospective, single-center, open label study designed to evaluate the clinical use of the StimRouter (STR) as a peripheral nerve stimulation device for the treatment of chronic pain. The clinical study is proposed to serve as an evaluation of the preliminary StimRouter design, proposed implantation techniques, electrical stimulation parameters, and outcome measures for the StimRouter. The current study will utilize the median nerve (in the context of carpal tunnel syndrome (CTS), status-post a single failed carpal tunnel release (CTR) surgery)as a model to represent the device's more general intended use as a peripheral nerve stimulator to treat chronic pain.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StimRouter (SR) for CTS | Experimental | Percutaneous implantation of StimRouter System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StimRouter System | Device | Implanted with StimRouter System receive 6 hours (or less if not tolerated by the Subject)of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming) |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Success | Success of device implantation was defined as uncomplicated minimally-invasive implantation of the StimRouter Lead near the targeted peripheral median nerve, resulting in production of desired paresthesias in the sensory distribution of the median nerve when active peripheral nerve stimulation was applied. This outcome parameter was intended to serve as an indication that the lead and electrode stimulating positions could be correctly placed while still maintaining the minimal invasiveness of the procedure. Fluoroscopic imaging was used to document positioning of the StimRouter Lead and, by applying stimulation from a commercially available Dakmed External Pulse Generator (EPG) to the StimRouter Lead, desired paresthesia response was confirmed. | at device implantation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patent Satisfaction | Numerical rating scale (NRS) of 0-10 where 0 = not satisfied and 10 = very satisfied | Day 5 after final stimulation |
| Percent of Participants Reporting Pain Change From Baseline to Day 5 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Evan L. Rosenfeld, MD, JD | Bioness Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Pain Relief | Charleston | West Virginia | 25301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15100589 | Background | Eisenberg E, Waisbrod H, Gerbershagen HU. Long-term peripheral nerve stimulation for painful nerve injuries. Clin J Pain. 2004 May-Jun;20(3):143-6. doi: 10.1097/00002508-200405000-00003. | |
| 10998746 | Background | Day M. Neuromodulation: spinal cord and peripheral nerve stimulation. Curr Rev Pain. 2000;4(5):374-82. doi: 10.1007/s11916-000-0021-7. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | StimRouter Stimulation | Percutaneous implantation of StimRouter System StimRouter System: Patient is Implanted with StimRouter System lead and receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
6. Pain relief by local anesthetic block of target nerve 7. Give informed consent 8. Quantify pain using 0 to 10 NRS
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | StimRouter (SR) Active Stimulation | Percutaneous implantation of StimRouter System StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Implant Success | Success of device implantation was defined as uncomplicated minimally-invasive implantation of the StimRouter Lead near the targeted peripheral median nerve, resulting in production of desired paresthesias in the sensory distribution of the median nerve when active peripheral nerve stimulation was applied. This outcome parameter was intended to serve as an indication that the lead and electrode stimulating positions could be correctly placed while still maintaining the minimal invasiveness of the procedure. Fluoroscopic imaging was used to document positioning of the StimRouter Lead and, by applying stimulation from a commercially available Dakmed External Pulse Generator (EPG) to the StimRouter Lead, desired paresthesia response was confirmed. | Posted | Number | participants with successful implant | at device implantation procedure |
|
Adverse events were collected from screening throughout the five days of StimRouter stimulation.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | StimRouter (SR) Active Stimulation | Percutaneous implantation of StimRouter System StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Throbbing in arm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Non-device related throbbing in arm after screening visit was mild transient and resulted on no sequelae. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith McBride, CTO | Bioness | 661-362-4866 | Keith.McBride@bioness.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020423 | Median Neuropathy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Brief Pain Inventory (BPI) questions 14 and 15 were used to measure pain change after 5 days use of StimRouter System. In the BPI, an 11-point numerical rating scale (NRS) is used to rate pain intensity, where zero (0) indicates ''no pain'' and 10 indicates ''pain as bad as you can imagine.'' At enrollment, participants circled the number that best described how much baseline pain they had 'on average' (BPI #14). After enrollment and during the study, patients circled the one number that best described how much pain they had at that time 'right now' (BPI #15). The percent of participants with change from Baseline to Day 5 was calculated.
| Day 5 |
| Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5 | Using Brief Pain Inventory questions 14 and 15, those 9 subjects who had pain change from Baseline to Day 5 were analyzed to determine change in pain for the overall group. In the BPI, an 11-point NRS is used to rate pain intensity, with a 0 for ''no pain'' and a 10 for ''pain as bad as you can imagine.'' At Baseline, patients circled the number that best described how much baseline pain they had 'on average' (BPI #14). During the study, patients circled the one number that best described how much pain they had at the time 'right now' (BPI #15). | Day 5 after final stimulation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Average pain level | Brief Pain Inventory (BPI) is an 11-point numerical rating scale (NRS) used to rate pain intensity, where zero (0) indicates ''no pain'' and 10 indicates ''pain as bad as you can imagine.'' At enrollment, participants circled the number that best described how much baseline pain they had 'on average' (mean score). | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Patent Satisfaction | Numerical rating scale (NRS) of 0-10 where 0 = not satisfied and 10 = very satisfied | All ten subjects responses were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Day 5 after final stimulation |
|
|
|
| Secondary | Percent of Participants Reporting Pain Change From Baseline to Day 5 | Brief Pain Inventory (BPI) questions 14 and 15 were used to measure pain change after 5 days use of StimRouter System. In the BPI, an 11-point numerical rating scale (NRS) is used to rate pain intensity, where zero (0) indicates ''no pain'' and 10 indicates ''pain as bad as you can imagine.'' At enrollment, participants circled the number that best described how much baseline pain they had 'on average' (BPI #14). After enrollment and during the study, patients circled the one number that best described how much pain they had at that time 'right now' (BPI #15). The percent of participants with change from Baseline to Day 5 was calculated. | All ten participants were analyzed. | Posted | Number | percentage of patients | Day 5 |
|
|
|
| Secondary | Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5 | Using Brief Pain Inventory questions 14 and 15, those 9 subjects who had pain change from Baseline to Day 5 were analyzed to determine change in pain for the overall group. In the BPI, an 11-point NRS is used to rate pain intensity, with a 0 for ''no pain'' and a 10 for ''pain as bad as you can imagine.'' At Baseline, patients circled the number that best described how much baseline pain they had 'on average' (BPI #14). During the study, patients circled the one number that best described how much pain they had at the time 'right now' (BPI #15). | Nine subjects who reported change after 5 days of StimRouter System use are analyzed to determine mean change in pain from Baseline to Day 5 of Stimulation for the overall group. | Posted | Mean | Standard Deviation | units on a scale | Day 5 after final stimulation |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
|
| allergic reaction to antiseptic | Immune system disorders | Non-systematic Assessment | Non-device related Bacitracin reaction |
|
| Seizure | Nervous system disorders | Non-systematic Assessment | non-device related seizure prior to device implantation procedure |
|
Not provided
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |