Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves (StimRouter)
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|ClinicalTrials.gov Identifier: NCT00665132|
Recruitment Status : Completed
First Posted : April 23, 2008
Results First Posted : June 6, 2016
Last Update Posted : June 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Unilateral Carpal Tunnel Syndrome||Device: StimRouter System||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Experimental: StimRouter (SR) for CTS
Percutaneous implantation of StimRouter System
Device: StimRouter System
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)
- Implant Success [ Time Frame: at device implantation procedure ]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.
- Patent Satisfaction [ Time Frame: Day 5 after final stimulation ]Numerical rating scale (NRS) of 0-10 where 0 = not satisfied and 10 = very satisfied
- Percent of Participants Reporting Pain Change From Baseline to Day 5 [ Time Frame: 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.
- Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5 [ Time Frame: Day 5 after final stimulation ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665132
|United States, West Virginia|
|The Center for Pain Relief|
|Charleston, West Virginia, United States, 25301|
|Study Director:||Evan L. Rosenfeld, MD, JD||Bioness Inc|