Trial Outcomes & Findings for A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes (NCT NCT01923662)

NCT ID: NCT01923662

Last Updated: 2025-08-22

Results Overview

The investigators will assess standing performance in terms of elapsed standing time. The investigators will also collect data related to subjective impression of stability.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 12 months post-rehabilitation
• Results posted on: 2025-08-22

Participant Flow

Participant milestones

Measure	Neuroprosthesis Eligible subjects will receive an implanted device (IRS-8 or IST-16) and surgically implanted electrodes to excite muscles that move paralyzed muscles. These electrodes are connected to the implanted stimulator that delivers electrical pulses to the nerves. These pulses cause the muscles to contract to perform functional movements or to exercise. IST-16 (16-Channel implanted stimulator-telemeter: Surgical implantation of IST-16 stimulator and electrodes to stimulate paralyzed muscles. Subjects will receive exercise and physical therapy with the implanted device. Functional training and laboratory assessments of clinical and technical performance will be conducted.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Neuroprosthesis Eligible subjects will receive an implanted device (IRS-8 or IST-16) and surgically implanted electrodes to excite muscles that move paralyzed muscles. These electrodes are connected to the implanted stimulator that delivers electrical pulses to the nerves. These pulses cause the muscles to contract to perform functional movements or to exercise. IST-16 (16-Channel implanted stimulator-telemeter: Surgical implantation of IST-16 stimulator and electrodes to stimulate paralyzed muscles. Subjects will receive exercise and physical therapy with the implanted device. Functional training and laboratory assessments of clinical and technical performance will be conducted.

Overall Study Withdrawal by Subject

1

Baseline Characteristics

A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes

Baseline characteristics by cohort

Measure	Neuroprosthesis n=6 Participants Eligible subjects will receive an implanted device (IRS-8 or IST-16) and surgically implanted electrodes to excite muscles that move paralyzed muscles. These electrodes are connected to the implanted stimulator that delivers electrical pulses to the nerves. These pulses cause the muscles to contract to perform functional movements or to exercise.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 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	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post-rehabilitation

Population: 5 participants with spinal cord injury with an implanted IST-16

The investigators will assess standing performance in terms of elapsed standing time. The investigators will also collect data related to subjective impression of stability.

Outcome measures

Measure	Neuroprosthesis n=5 Participants Eligible subjects will receive an implanted device (IRS-8 or IST-16) and surgically implanted electrodes to excite muscles that move paralyzed muscles. These electrodes are connected to the implanted stimulator that delivers electrical pulses to the nerves. These pulses cause the muscles to contract to perform functional movements or to exercise.
Average Standing Performance in Terms of Elapsed Standing Time for All Subjects.	32.6 Minutes Standard Deviation 23.3

SECONDARY outcome

Timeframe: 12 months post-rehabilitation

Population: 5 participants with spinal cord injury with an implanted IST-16

Determine the amount of weight on both legs during standing with stimulation.

Outcome measures

Measure	Neuroprosthesis n=5 Participants Eligible subjects will receive an implanted device (IRS-8 or IST-16) and surgically implanted electrodes to excite muscles that move paralyzed muscles. These electrodes are connected to the implanted stimulator that delivers electrical pulses to the nerves. These pulses cause the muscles to contract to perform functional movements or to exercise.
Percentage of Body Weight Distribution on the Legs While Standing With Stimulation.	92.7 % of body weight on lower extremity Standard Deviation .05

Adverse Events

Neuroprosthesis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ronald J Triolo

VAORD

Phone: 216-791-3800

Email: Ronald.Triolo@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place