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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgery
IRS-8
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring environmental/toxic disorders, neurologic and psychiatric disorders, rare disease, spinal cord injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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.) Exclusion Criteria: Failure to meet inclusion criteria

Sites / Locations

  • Case Western Reserve University
  • MetroHealth System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implanted Neuroprosthesis

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Distribution of Body Weight Through the Legs and Arms While Standing
Measure of how much weight is placed on the legs and arms while standing

Full Information

First Posted
October 18, 1999
Last Updated
October 4, 2022
Sponsor
Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT00004445
Brief Title
Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injuries
Official Title
Eight Channel Implanted Neuroprosthesis for Exercise, Standing and Transfers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 1996 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University

4. Oversight

5. Study Description

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.
Detailed Description
PROTOCOL OUTLINE: Patients undergo surgery in which electrodes are sutured into areas of the pelvis and legs. Electrode leads are inserted into a receiver/stimulator implanted in a subcutaneous pocket in the abdomen. Following implantation, patients undergo training in standing, transfers, and other advanced mobility skills using the functional neuromuscular stimulation system. Restricted activity continues for 2 weeks after surgery, followed by 8 weeks of exercise. Standing training then begins, and continues for up to 6 weeks. Home-based training follows prior to discharge with the system for spontaneous use. Patients are followed at 3, 6, and 12 months, then annually thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
environmental/toxic disorders, neurologic and psychiatric disorders, rare disease, spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implanted Neuroprosthesis
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Type
Device
Intervention Name(s)
IRS-8
Primary Outcome Measure Information:
Title
Standing Performance
Description
A measure of how long an individual can maintain a standing position.
Time Frame
Discharge, 1 follow-up between 6-12 months follow-up
Secondary Outcome Measure Information:
Title
Distribution of Body Weight Through the Legs and Arms While Standing
Description
Measure of how much weight is placed on the legs and arms while standing
Time Frame
Discharge, 1 follow-up between 6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.) Exclusion Criteria: Failure to meet inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald J. Triolo
Organizational Affiliation
Case Western Reserve University
Official's Role
Study Chair
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28899825
Citation
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.
Results Reference
derived
PubMed Identifier
22773528
Citation
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.
Results Reference
derived
PubMed Identifier
22541312
Citation
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.
Results Reference
derived

Learn more about this trial

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

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