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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
First received
Last updated
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
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 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

Study Design


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
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