IST-16 (16-channel implanted stimulator-telemeter) for Spinal Cord Injury
Phase-Based Progress Estimates
Effectiveness
Safety
MetroHealth System, Cleveland, OHSpinal Cord Injury+4 MoreIST-16 (16-channel implanted stimulator-telemeter) - Device
Study Summary
This trial will test a surgically-implanted device that sends electrical signals to the muscles, to help people with paralysis exercise, stand, and/or maintain balance.
Eligible Conditions
- Spinal Cord Injury
- Quadriplegia
- Paralysis
- Paraplegia
- Stroke
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: Change from immediately after intervention and 1 year after intervention
Year 1
Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge
Device reliability and technical performance measuring changes in standing from baseline at discharge to 12 months after discharge
Device reliability and technical performance measuring changes in walking from baseline at discharge to 12 months after discharge
Trial Safety
Trial Design
1 Treatment Group
A
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: IST-16 (16-channel implanted stimulator-telemeter) · No Placebo Group · N/A
A
Device
Experimental Group · 1 Intervention: IST-16 (16-channel implanted stimulator-telemeter) · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from immediately after intervention and 1 year after intervention
Who is running the clinical trial?
Case Western Reserve UniversityLead Sponsor
276 Previous Clinical Trials
198,471 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,471 Previous Clinical Trials
24,591,538 Total Patients Enrolled
US Department of Veterans AffairsFED
854 Previous Clinical Trials
470,339 Total Patients Enrolled
Musa L Audu, Ph.D.Principal InvestigatorLouis Stokes Cleveland VA Medical Center
Ronald J Triolo, Ph.D.Principal InvestigatorCase Western Reserve University
Eligibility Criteria
Age 21 - 75 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are able to move your body normally.
You have a serious injury or condition that has caused paralysis in the lower part of your body, specifically from the neck down to the middle of your back.
Your bones are fully developed.
Who else is applying?
What state do they live in?
| Florida | 33.3% |
| Ohio | 33.3% |
| Pennsylvania | 33.3% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Louis Stokes Cleveland VA Medical Center | 25.0% |
| MetroHealth System | 75.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "I’m excited to try and improve my life"
- "I have more life to live and I want to improve my condition. I also want to possibly help others with this new technology."
How many prior treatments have patients received?
| 0 | 100.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |
Most responsive sites:
- MetroHealth System: < 48 hours
Average response time
- < 2 Days
References
- Lee E. Fisher, Michael E. Miller, Stephanie J. Nogan, John A. Davis, James S. Anderson, Lori M. Murray, Dustin J. Tyler, and Ronald J. Triolo. 2006. “Preliminary Evaluation of a Neural Prosthesis for Standing After Spinal Cord Injury with Four Contact Nerve-cuff Electrodes for Quadriceps Stimulation”. 2006 International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE. doi:10.1109/iembs.2006.260833.
- Dutta, Anirban, Rudi Kobetic, and Ronald J. Triolo. 2006. “Ambulation After Incomplete Spinal Cord Injury with Electromyogram-triggered Functional Electrical Stimulation”. 2006 International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE. doi:10.1109/iembs.2006.259257.
- Uhlir, J.P., R.J. Triolo, J.A. Davis, and C. Bieri. 2004. “Performance of Epimysial Stimulating Electrodes in the Lower Extremities of Individuals with Spinal Cord Injury”. IEEE Transactions on Neural Systems and Rehabilitation Engineering. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tnsre.2004.827224.
- Triolo, Ronald J., Stephanie Nogan Bailey, Kevin M. Foglyano, Rudi Kobetic, Lisa M. Lombardo, Michael E. Miller, and Gilles Pinault. 2018. “Long-term Performance and User Satisfaction with Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-year Follow-up”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2017.08.470.
- Uhlir, J.P., R.J. Triolo, J.A. Davis, and C. Bieri. 2004. “Performance of Epimysial Stimulating Electrodes in the Lower Extremities of Individuals with Spinal Cord Injury”. IEEE Transactions on Neural Systems and Rehabilitation Engineering. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tnsre.2004.827224.
- Forrest, George P., Thomas C. Smith, Ronald J. Triolo, Jason Gagnon, Darryl DiRisio, Michael E. Miller, and Lori Rhodi. 2011. “Use of the Case Western Reserve/veterans Administration Neuroprosthesis for Exercise, Standing and Transfers by a Paraplegic Subject”. Disability and Rehabilitation: Assistive Technology. Informa UK Limited. doi:10.3109/17483107.2011.629328.
- Mushahwar, Vivian K, Patrick L Jacobs, Richard A Normann, Ronald J Triolo, and Naomi Kleitman. 2007. “New Functional Electrical Stimulation Approaches to Standing and Walking”. Journal of Neural Engineering. IOP Publishing. doi:10.1088/1741-2560/4/3/s05.
- Bogie, Kath M., and Ronald J. Triolo. 2003. “Effects of Regular Use of Neuromuscular Electrical Stimulation on Tissue Health”. The Journal of Rehabilitation Research and Development. Journal of Rehabilitation Research & Development. doi:10.1682/jrrd.2003.11.0469.
- Uhlir, J.P., R.J. Triolo, J.A. Davis, and C. Bieri. 2004. “Performance of Epimysial Stimulating Electrodes in the Lower Extremities of Individuals with Spinal Cord Injury”. IEEE Transactions on Neural Systems and Rehabilitation Engineering. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tnsre.2004.827224.
- Mushahwar, Vivian K, Patrick L Jacobs, Richard A Normann, Ronald J Triolo, and Naomi Kleitman. 2007. “New Functional Electrical Stimulation Approaches to Standing and Walking”. Journal of Neural Engineering. IOP Publishing. doi:10.1088/1741-2560/4/3/s05.
- Mushahwar VK, Jacobs PL, Normann RA, Triolo RJ, Kleitman N. New functional electrical stimulation approaches to standing and walking. J Neural Eng. 2007 Sep;4(3):S181-97. doi: 10.1088/1741-2560/4/3/S05. Epub 2007 Aug 22.
- Uhlir JP, Triolo RJ, Davis JA Jr, Bieri C. Performance of epimysial stimulating electrodes in the lower extremities of individuals with spinal cord injury. IEEE Trans Neural Syst Rehabil Eng. 2004 Jun;12(2):279-87. doi: 10.1109/TNSRE.2004.827224.
- Dutta A, Kobetic R, Triolo RJ. Ambulation after incomplete spinal cord injury with electromyogram-triggered functional electrical stimulation. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:5408-11. doi: 10.1109/IEMBS.2006.259257.
- Bogie KM, Triolo RJ. Effects of regular use of neuromuscular electrical stimulation on tissue health. J Rehabil Res Dev. 2003 Nov-Dec;40(6):469-75. doi: 10.1682/jrrd.2003.11.0469.
- Fisher LE, Miller ME, Nogan SJ, Davis JA, Anderson JS, Murray LM, Tyler DJ, Triolo RJ. Preliminary evaluation of a neural prosthesis for standing after spinal cord injury with four contact nerve-cuff electrodes for quadriceps stimulation. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:3592-5. doi: 10.1109/IEMBS.2006.260833.
- Ronald J. Triolo 2018. "Evaluation of an Advanced Lower Extremity Neuroprostheses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00623389.
Frequently Asked Questions
Are there current opportunities to participate in this trial?
"Clinicaltrials.gov affirms that this medical study, which first opened to the public on June 1st 2018, is actively recruiting volunteers. Its last update was posted 5th October 2022." - Anonymous Online Contributor
Unverified Answer
How many participants are being treated as part of this experiment?
"Affirmative. According to clinicaltrials.gov, this medical program is actively enrolling participants since June 1st 2018 and its information was last revised on October 5th 2022. The researchers are in pursuit of 10 individuals from two separate facilities for the trial." - Anonymous Online Contributor
Unverified Answer
Is this study accepting volunteers of a mature age?
"The protocol of this medical trial specifies that the minimum age for participation is 21 years old and the maximum age limit is 75." - Anonymous Online Contributor
Unverified Answer
Is my eligibility sufficient to participate in this research?
"Eligibility requirements for this clinical trial necessitate that applicants have quadriplegia, with an age range of 21 to 75 years old. Only 10 participants may be accepted into the study." - Anonymous Online Contributor
Unverified Answer