CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
Surgery +1 moreprocedure
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Low cervical (C6) or thoracic (T12) spinal cord injuries
  • ✓Skeletally mature
  • ✓ASIA impairment scale A, B, or C
  • ✓Intact lower motor neurons
Key exclusion· 7
  • ✕Renal compromise
  • ✕Cardiac abnormalities
  • ✕Circulatory compromise
  • ✕Pulmonary compromise

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00004445
NCT00004445N/ACompleted
CompareCT.gov

Eight Channel Implanted Neuroprosthesis for Exercise, Standing and Transfers

Case Western Reserve University·interventional·Posted Oct 19, 1999·Updated May 20, 2025

In Brief

A clinical study evaluating Surgery and IRS-8 for Spinal Cord Injury. Completed, enrolled 18 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injury
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 1999
Enrollment StartSep 1, 1996
Primary CompletionSep 1, 2009
Study CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 13 yearsPosted 26.7 years ago

Interventions

Surgeryprocedure

IRS-8device