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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00623389
Other study ID # EB-001889
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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