Trial Outcomes & Findings for Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves (NCT NCT00665132)

Last Updated: 2016-06-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

at device implantation procedure

Results posted on

2016-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	StimRouter (SR) Active Stimulation n=10 Participants 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).
Age, Continuous	53.7 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Average pain level	6.7 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants

PRIMARY outcome

Timeframe: at device implantation procedure

Outcome measures

Outcome measures
Measure	StimRouter (SR) Active Stimulation n=10 Participants 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).
Implant Success	10 participants with successful implant

SECONDARY outcome

Timeframe: Day 5 after final stimulation

Population: All ten subjects responses were analyzed.

Numerical rating scale (NRS) of 0-10 where 0 = not satisfied and 10 = very satisfied

Outcome measures

Outcome measures
Measure	StimRouter (SR) Active Stimulation n=10 Participants 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).
Patent Satisfaction	9.6 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Day 5

Population: All ten participants were analyzed.

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.

Outcome measures

Outcome measures
Measure	StimRouter (SR) Active Stimulation n=10 Participants 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).
Percent of Participants Reporting Pain Change From Baseline to Day 5	90 percentage of patients

SECONDARY outcome

Timeframe: Day 5 after final stimulation

Population: 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.

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).

Outcome measures

Outcome measures
Measure	StimRouter (SR) Active Stimulation n=9 Participants 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).
Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5	2.9 units on a scale Standard Deviation 2.0

Adverse Events

StimRouter (SR) Active Stimulation

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	StimRouter (SR) Active Stimulation n=10 participants at risk 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).
Musculoskeletal and connective tissue disorders Throbbing in arm	10.0% 1/10 • Number of events 1 • Adverse events were collected from screening throughout the five days of StimRouter stimulation.
Immune system disorders allergic reaction to antiseptic	10.0% 1/10 • Number of events 1 • Adverse events were collected from screening throughout the five days of StimRouter stimulation.
Nervous system disorders Seizure	10.0% 1/10 • Number of events 1 • Adverse events were collected from screening throughout the five days of StimRouter stimulation.

Additional Information

Keith McBride, CTO

Bioness

Phone: 661-362-4866

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60