NCT00004445

Brief Summary

OBJECTIVES: I. Establish the procedures for implementing and assessing the clinical utility of functional neuromuscular stimulation using an implanted eight-channel standing and transfer system in patients with incomplete tetraplegia or paraplegia. II. Develop and apply quantitative functional evaluations of system performance in these patients. III. Perform long term follow up and monitor system use outside of the laboratory.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 1996

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1996

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 22, 2019

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

13 years

First QC Date

October 18, 1999

Results QC Date

March 5, 2019

Last Update Submit

May 12, 2025

Conditions

Spinal Cord Injury

Keywords

environmental/toxic disordersneurologic and psychiatric disordersrare diseasespinal cord injury

Outcome Measures

Primary Outcomes (1)

  • Standing Performance

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

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

Secondary Outcomes (1)

  • Distribution of Body Weight Through the Legs and Arms While Standing

    Discharge, 1 follow-up between 6-12 months

Study Arms (1)

Implanted Neuroprosthesis

EXPERIMENTAL

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

Procedure: SurgeryDevice: IRS-8

Interventions

SurgeryPROCEDURE
Implanted Neuroprosthesis
IRS-8DEVICE
Implanted Neuroprosthesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low cervical or thoracic spinal cord injuries (C6-T12) Must be skeletally mature ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing), or C (motor and sensory sparing) Intact lower motor neurons Greater than 6 months since injury Range of motion within normal limits No renal compromise No cardiac abnormalities No circulatory compromise No pulmonary compromise No acute or chronic psychological problems or chemical dependency No acute orthopedic complications (scoliosis, history of spontaneous fractures, dislocations, etc.) No acute medical complications (no skin breakdowns, uncontrolled seizures, immunological compromise, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MetroHealth System

Cleveland, Ohio, 44109, United States

Location

Related Publications (3)

  • Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9.

    PMID: 28899825DERIVED

  • Rohde LM, Bonder BR, Triolo RJ. Exploratory study of perceived quality of life with implanted standing neuroprostheses. J Rehabil Res Dev. 2012;49(2):265-78. doi: 10.1682/jrrd.2010.08.0156.

    PMID: 22773528DERIVED

  • Triolo RJ, Bailey SN, Miller ME, Rohde LM, Anderson JS, Davis JA Jr, Abbas JJ, DiPonio LA, Forrest GP, Gater DR Jr, Yang LJ. Longitudinal performance of a surgically implanted neuroprosthesis for lower-extremity exercise, standing, and transfers after spinal cord injury. Arch Phys Med Rehabil. 2012 May;93(5):896-904. doi: 10.1016/j.apmr.2012.01.001.

    PMID: 22541312DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesNeurologic ManifestationsMental DisordersRare Diseases

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Results Point of Contact

Title
Lisa Lombardo, MPT
Organization
Louis Stokes Cleveland VAMC
lisa.lombardo2@va.gov
216-791-3800

Study Officials

  • Ronald J. Triolo

    Case Western Reserve University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Biomedical Enginer

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

September 1, 1996

Primary Completion

September 1, 2009

Study Completion

December 31, 2016

Last Updated

May 20, 2025

Results First Posted

July 22, 2019

Record last verified: 2025-05

Locations

US(2)