Clinical trial NCT00623389: Evaluation of an Advanced Lower Extremity Neuroprostheses
Official title: Evaluation of Advanced Lower Extremity Neuroprostheses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Stroke
Paralysis
Tetraplegia
Paraplegia
Keywords: Neurologic disorders
Rare disease
Spinal cord injuries
Stroke
Paraplegia
Tetraplegia
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2008-02-26
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Detailed 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.

Eligibility criteria: Phase I Inclusion Criteria

1. Skeletal maturity and ability to sign informed consent (\>18 years)
2. Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
3. Innervated and excitable lower extremity and trunk musculature
4. Adequate social support and stability
5. Willingness to comply with follow-up procedures

Phase I Exclusion Criteria

1. Non-English speaking
2. Females who are pregnant
3. Current pressure injuries that would be exacerbated by study activities
4. Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities
5. History of spontaneous fractures or other evidence of excessively low bone density
6. History of vestibular dysfunction, balance problems, or spontaneous falls
7. Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.

Primary outcomes:
measure: Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge
timeFrame: Change from immediately after intervention and 1 year after intervention
measure: Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge
timeFrame: Change from immediately after intervention and 1 year after intervention
measure: Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge
timeFrame: Change from immediately after intervention and 1 year after intervention
measure: Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge
timeFrame: Change from immediately after intervention and 1 year after intervention
Secondary outcomes:
measure: Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge
timeFrame: Change from immediately after intervention and 1 year after intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes Cleveland VA Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Ronald J Triolo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Louis Stokes Cleveland VA Medical Center
name: Musa L Audu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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 Eng Med Biol Soc. 2006;2006:3592-5. doi: 10.1109/IEMBS.2006.260833.
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.
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.
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.
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.
citation: 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.
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.
citation: Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9.