Trial Outcomes & Findings for Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injuries (NCT NCT00004445)

NCT ID: NCT00004445

Last Updated: 2025-05-20

Results Overview

A measure of how long an individual can maintain a standing position.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: Discharge, 1 follow-up between 6-12 months follow-up
• Results posted on: 2025-05-20

Participant Flow

Recruitment of participants is based on evaluation of past medical history and in person evaluation including strength, ROM, and response to stimulation to determine eligibility.

Participants will go through a screening process that will determine eligibility for the study. If they don't meet the inclusion or exclusion criteria they will not be invited to continue to the second phase of the study.

Participant milestones

Measure	Implanted Neuroprosthesis Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in \[ost-operative training and follow-up procedures. Surgery IRS-8
Overall Study STARTED	18
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Implanted Neuroprosthesis Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in \[ost-operative training and follow-up procedures. Surgery IRS-8
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injuries

Baseline characteristics by cohort

Measure	Implanted Neuroprosthesis n=15 Participants Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in \[ost-operative training and follow-up procedures. Surgery IRS-8
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33.7 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Discharge, 1 follow-up between 6-12 months follow-up

A measure of how long an individual can maintain a standing position.

Outcome measures

Measure	Implanted Neuroprosthesis n=15 Participants Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures. Interventions include: Procedure/Surgery Rehabilitation/Exercise Device includes: IRS-8 Stimulating Electrodes External Controller Surgery IRS-8
Standing Performance 6-12 month follow-up standing time	15.6 minutes Standard Deviation 21.8
Standing Performance Discharge standing time	27.4 minutes Standard Deviation 38.6

SECONDARY outcome

Timeframe: Discharge, 1 follow-up between 6-12 months

Measure of how much weight is placed on the legs and arms while standing

Outcome measures

Measure	Implanted Neuroprosthesis n=15 Participants Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures. Interventions include: Procedure/Surgery Rehabilitation/Exercise Device includes: IRS-8 Stimulating Electrodes External Controller Surgery IRS-8
Distribution of Body Weight Through the Legs and Arms While Standing Discharge body weight distribution	90.0 percentage of body weight Standard Deviation 13.1
Distribution of Body Weight Through the Legs and Arms While Standing 6-12 month follow-up body weight distribution	76.7 percentage of body weight Standard Deviation 22.2

Adverse Events

Implanted Neuroprosthesis

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Implanted Neuroprosthesis n=15 participants at risk Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in \[ost-operative training and follow-up procedures. Surgery IRS-8
Infections and infestations Infection	6.7% 1/15 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Lisa Lombardo, MPT

Louis Stokes Cleveland VAMC

Phone: 216-791-3800

Email: lisa.lombardo2@va.gov

Results disclosure agreements

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