Completed

Eight Channel Implanted Neuroprosthesis for Exercise, Standing and Transfers

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What is being tested

Surgery

+ IRS-8

ProcedureDevice
Who is being recruted

Central Nervous System Diseases+10

+ Nervous System Diseases

+ Pathologic Processes

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 1996
See protocol details

Summary

Principal SponsorCase Western Reserve University
Last updated: May 20, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00004445
Principal SponsorCase Western Reserve University
Last updated: May 20, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Central Nervous System DiseasesNervous System DiseasesPathologic ProcessesSigns and SymptomsSpinal Cord DiseasesPathological Conditions, Signs and SymptomsWounds and InjuriesTrauma, Nervous SystemDisease AttributesMental DisordersNeurologic ManifestationsSpinal Cord InjuriesRare Diseases

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Case Western Reserve University

Cleveland, United StatesOpen Case Western Reserve University in Google Maps

MetroHealth System

Cleveland, United States
Completed2 Study Centers