A Neuroprosthesis for Seated Posture and Balance

Spinal Cord Injury Clinical Trial

— Trunk Protocol  

Official title:

A Neuroprosthesis for Seated Posture and Balance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01474148
• Other study ID #: A1204-R
• Secondary ID: IRB#07101-H36
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2011
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• 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 stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.

Description:

In a single surgical procedure electrodes will be inserted into muscles of the trunk and hip musculature. The electrode leads are connected to a stimulator/telemeter located in the abdomen. After a typical post-operative period of two to five days, neuroprosthesis recipients will be discharged to home for two to six weeks of restricted activity to promote healing of all surgical incisions. After a period of exercise and training, functional use of the neuroprosthesis will begin. Laboratory assessments of strength, balance, and functional abilities with and without the system, as well as the technical performance of the implanted components will be evaluated.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• C4-T12

• ASIA Scale A through C

• Time post injury greater than 6 months

• Innervated and excitable trunk and pelvis musculature

• Absence of acute or chronic psychological problems or chemical dependency

• Range of motion within normal limits

• Controlled spasticity and absence of hip flexion and adduction spasm

• Height and weight within normal limits

• No history of balance problems or spontaneous falls

• No history of spontaneous fracture or evidence low bone density

• No acute orthopaedic problems

• No acute medical complications

• Adequate social support and stability

• Able to speak and read English

Exclusion Criteria:

• Pregnancy

• Non-English speaking

Related Conditions & MeSH terms

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

Intervention

Device:
• IRS-8 (8-Channel implanted stimulator-telemeter)
Surgical implantation of the 8-channel neuroprosthesis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Triolo RJ, Boggs L, Miller ME, Nemunaitis G, Nagy J, Bailey SN. Implanted electrical stimulation of the trunk for seated postural stability and function after cervical spinal cord injury: a single case study. Arch Phys Med Rehabil. 2009 Feb;90(2):340-7. doi: 10.1016/j.apmr.2008.07.029. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility.	Experiments involving the effects of trunk stimulation on postural alignment; trunk stability and posture on respiration, postural variation on seated interface pressures; effects of trunk stimulation on reaching ability; effects of trunk stimulation on seated stability, and personal mobility.	up to 36 months
Secondary	Design a simple position controller	The position controller will be developed to keep the trunk posture at a neutral seated position while allowing movement to lean forward, backward, or side-to-side. Testing will be carried out with an automated pull system applied to the trunk which pulls the body in various ways (side-to-side, forward, backward)	Up to 36 months

External Links

•   Cleveland FES center website