Evaluation of an Advanced Lower Extremity Neuroprostheses

Stroke Clinical Trial

— LE-IST  

Official title:

Evaluation of Advanced Lower Extremity Neuroprostheses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00623389
• Other study ID #: EB-001889
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: May 31, 2025

Study information

• Verified date: October 2023
• Source: Case Western Reserve University
• Contact: Lisa M Lombardo, MPT
• Phone: 216-791-3800
• Email: lisa.lombardo2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.

Description:

Protocol Outline: Patents undergo surgery in which electrodes are implanted into muscles of the trunk and legs. Electrode leads are connected to an stimulator/telemeter. Following implantation, patients undergo training in standing, transfers and other advanced mobility skills using the functional electrical stimulation system. A prescribed course of exercise, functional training and rehabilitation with the implanted stimulation system, followed by laboratory assessments of strength, balance and functional abilities with and without the system, as well as the technical performance of the implanted components. Home-based training follows prior to discharge for home use of the system.

Patients are followed at 6 and 12 months after discharge and then annually thereafter.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Low cervical or thoracic spinal cord injury (C6-T12) or other paralyzing condition

• Skeletal maturity

• Ability to understand and sign informed consents

• Disability equivalent to ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing) or C (motor and sensory sparing)

• Intact and electrically excitable lower motor neurons

• Greater than 6 months since injury or onset

• Range of motion within normal limits

Exclusion Criteria:

• Pacemaker

• Cardiac arrythmia

• Pregnancy

• Contractures of any major joint of upper or lower extremities

• Uncontrolled seizure disorder

• Obesity

• Untreated substance abuse

• Immunodeficiency

• Frequent urinary tract infections

• Presence of decubitis ulcers

• Acute or chronic psychological problems

• Acute orthopaedic problems

• Pulmonary compromise

• Renal compromise

• Circulatory compromise

• History of spontaneous fractures or insulin dependent diabetes

Related Conditions & MeSH terms

• Paralysis
• Paraplegia
• Quadriplegia
• Spinal Cord Injuries
• Stroke
• Tetraplegia

Intervention

Device:
• IST-16 (16-channel implanted stimulator-telemeter)
Pre-surgical exercise with surface electrical stimulation, surgery including electrode insertion and IST-16 stimulator/telemeter implantation, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.

Locations

Country	Name	City	State
United States	Louis Stokes Cleveland VA Medical Center	Cleveland	Ohio
United States	MetroHealth System	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institutes of Health (NIH), US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

References & Publications (7)

Agarwal S, Triolo RJ, Kobetic R, Miller M, Bieri C, Kukke S, Rohde L, Davis JA Jr. Long-term user perceptions of an implanted neuroprosthesis for exercise, standing, and transfers after spinal cord injury. J Rehabil Res Dev. 2003 May-Jun;40(3):241-52. — View Citation

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. — View Citation

Davis JA Jr, Triolo RJ, Uhlir J, Bieri C, Rohde L, Lissy D, Kukke S. Preliminary performance of a surgically implanted neuroprosthesis for standing and transfers--where do we stand? J Rehabil Res Dev. 2001 Nov-Dec;38(6):609-17. — View Citation

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. — View Citation

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 E — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge	Repeated measures of standing duration in minutes	Change from immediately after intervention and 1 year after intervention
Primary	Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge	Repeated measures of arm/leg loading measured in Kg	Change from immediately after intervention and 1 year after intervention
Primary	Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge	Repeated measures of walking distance in meters	Change from immediately after intervention and 1 year after intervention
Primary	Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge	Repeated measures of walking time in minutes	Change from immediately after intervention and 1 year after intervention
Secondary	Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge	Repeated measures of standing reach in cm, and transfer height in cm	Change from immediately after intervention and 1 year after intervention