A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes

Spinal Cord Injury Clinical Trial

Official title:

Exploiting Selective Recruitment to Prolong Standing After SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923662
• Other study ID #: B1039-R
• Status: Completed
• Phase: N/A
• Start date: April 11, 2013
• Est. completion date: March 18, 2024

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to improve the performance of neuroprosthesis for standing after SCI by developing and testing new advanced methods that use multiple contact peripheral nerve electrodes to slow the onset of fatigue and increase standing duration. The new advanced methods will take advantage of the ability of multiple-contact nerve cuff electrodes to selectively activate portions of a muscle that perform the same action. Alternating activation to multiple muscles (or parts of the same muscle) rather than continuously activation the entire muscle group constantly should allow them to rest and recover from fatiguing contractions. This should allow users to remain upright for longer periods of time to perform activities of daily living, reduce the risk of falls due to fatigue, and increase the potential of receiving the health benefits of standing.

Description:

Neuroprostheses for standing after SCI currently rely on continuous activation of the hip and knee extensor muscles, which results in rapid fatigue and ultimately compromises elapsed standing time. The primary objective of this study is to improve the performance of neuroprostheses for standing by developing and implementing advanced stimulation paradigms that use multi-contact peripheral nerve electrodes to delay fatigue onset and prolong standing duration. The new stimulation paradigms will take advantage of the ability of multi-contact nerve cuff electrodes to selectively activate independent portions of a muscle, or independent muscles that perform the same action. Such a capability will allow one or more muscles (or parts of the same muscle) to rest while the others continue to contract to keep the knee extended and the user upright. Stimulation waveforms that alternate activation to multiple muscles performing the same function, rather than continuously activate the entire muscle group constantly, should allow muscles to rest and recover from fatiguing contractions.

In addition to these important clinical benefits, the project is also of high impact and significance because the methods to be developed will not be specific to any single electrode technology or stimulation system. Any clinical or therapeutic application that requires a sustained muscular contraction or the production of constant joint torques for prolonged periods of time will benefit from the successful completion of this project.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 18, 2024
• Est. primary completion date: March 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Skeletal maturity (age 21 and above), and ability to sign informed consent

• Paralysis resulting from neurological disorder such as low cervical/thoracic spinal cord injuries (C6-T12)

• Time post injury greater than six months to assure neurological and emotional stability

• Innervated and excitable lower extremity and lumbar trunk musculature

• Absence of acute or chronic psychological problems or chemical dependency

• Range of motion within normal limits, (full extension at the hip and knee, and ability to attain a neutral ankle position)

• Controlled spasticity and absence of hip flexion and adduction spasms

• Appropriate body habitus (BMI within normal range)

• Adequate social support and stability

• Willingness to comply with follow-up procedures.

• Full coverage of the acetabulum and minimal knee and ankle laxity

Exclusion Criteria:

• History of vestibular dysfunction, balance problems or spontaneous falls.

• Acute orthopaedic problems: severe scoliosis or joint dislocation, severe osteoporosis.

• Acute medical complication: cardiac abnormalities, skin breakdowns, uncontrolled seizures, or immunological, pulmonary/ renal/ circulatory compromise, auto-immune deficiencies, sepsis, active infection, dental caries.

• Diabetes

• Non-English speaking subjects

• Pregnancy

Related Conditions & MeSH terms

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

Intervention

Device:
• IST-16 (16-Channel implanted stimulator-telemeter
Surgical implantation of IST-16 stimulator and electrodes to stimulate paralyzed muscles. Subjects will receive exercise and physical therapy with the implanted device. Functional training and laboratory assessments of clinical and technical performance will be conducted.

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Chae J, Kilgore K, Triolo R, Creasey G. Functional neuromuscular stimulation in spinal cord injury. Phys Med Rehabil Clin N Am. 2000 Feb;11(1):209-26, x. — 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

Davis JA Jr, Triolo RJ, Uhlir JP, Bhadra N, Lissy DA, Nandurkar S, Marsolais EB. Surgical technique for installing an eight-channel neuroprosthesis for standing. Clin Orthop Relat Res. 2001 Apr;(385):237-52. doi: 10.1097/00003086-200104000-00035. — View Citation

Fisher LE, Miller ME, Bailey SN, Davis JA Jr, Anderson JS, Rhode L, Tyler DJ, Triolo RJ. Standing after spinal cord injury with four-contact nerve-cuff electrodes for quadriceps stimulation. IEEE Trans Neural Syst Rehabil Eng. 2008 Oct;16(5):473-8. doi: 1 — View Citation

Fisher LE, Tyler DJ, Anderson JS, Triolo RJ. Chronic stability and selectivity of four-contact spiral nerve-cuff electrodes in stimulating the human femoral nerve. J Neural Eng. 2009 Aug;6(4):046010. doi: 10.1088/1741-2560/6/4/046010. Epub 2009 Jul 15. — View Citation

Uhlir JP, Triolo RJ, Kobetic R. The use of selective electrical stimulation of the quadriceps to improve standing function in paraplegia. IEEE Trans Rehabil Eng. 2000 Dec;8(4):514-22. doi: 10.1109/86.895955. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standing performance in terms of elapsed standing time will be compared across stimulation paradigms for each subject.	The investigators will assess standing performance in terms of elapsed standing time with various stimulation paradigms. The investigators will also collect data related to subjective impression of stability.	12 months post-rehabilitation
Secondary	Body weight distribution on the arms and legs will be compared across stimulation paradigms for each subject.	Determine the amount of weight on both arms and legs during standing. During standing performance the investigators will also assess standing stability in terms of variations in knee joint angle and location of body center of mass while standing with various stimulation paradigms.	12 months post-rehabilitation

External Links

•   APT Center is a VA Center of Excellence
•   FES Center is VA Center of excellence