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A Neuroprosthesis for Seated Posture and Balance (Trunk Protocol)

Primary Purpose

Spinal Cord Injury, Paralysis, Tetraplegia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

IRS-8 (8-Channel implanted stimulator-telemeter)

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring paraplegia, tetraplegia, Spinal cord injured, FES

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Louis Stokes VA Medical Center, Cleveland, OHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuroprosthesis

Arm Description

Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT01474148

First Posted

November 8, 2011

Last Updated

January 5, 2023

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT01474148

Brief Title

A Neuroprosthesis for Seated Posture and Balance

Acronym

Trunk Protocol

Official Title

A Neuroprosthesis for Seated Posture and Balance

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 30, 2011 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury, Paralysis, Tetraplegia, Paraplegia

Keywords

paraplegia, tetraplegia, Spinal cord injured, FES

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neuroprosthesis

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

IRS-8 (8-Channel implanted stimulator-telemeter)

Other Intervention Name(s)

Implanted Neuroprosthesis for Seated Posture and Balance, Trunk implanted electrical stimulation system, Implanted trunk control neuroprosthesis, Implanted FNS

Intervention Description

Surgical implantation of the 8-channel neuroprosthesis

Primary Outcome Measure Information:

Title

Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility.

Description

Time Frame

up to 36 months

Secondary Outcome Measure Information:

Title

Design a simple position controller

Description

Time Frame

Up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lisa M Lombardo, MPT

Phone

(216) 791-3800

Ext

4909

Lisa.Lombardo2@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Emily C Johnson, BA

Phone

(216) 791-3800

Ext

64904

emily.johnson17@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Triolo, PhD

Organizational Affiliation

Louis Stokes VA Medical Center, Cleveland, OH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Louis Stokes VA Medical Center, Cleveland, OH

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lisa M Lombardo, MPT

Phone

216-791-3800

Ext

4909

Lisa.Lombardo2@va.gov

First Name & Middle Initial & Last Name & Degree

Ronald Triolo, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19236990

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.

Results Reference

background

PubMed Identifier

15077659

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.

Results Reference

background

PubMed Identifier

32795162

Citation

Foglyano KM, Lombardo LM, Schnellenberger JR, Triolo RJ. Sudden stop detection and automatic seating support with neural stimulation during manual wheelchair propulsion. J Spinal Cord Med. 2022 Mar;45(2):204-213. doi: 10.1080/10790268.2020.1800278. Epub 2020 Aug 14.

Results Reference

derived

PubMed Identifier

29530053

Citation

Armstrong KL, Lombardo LM, Foglyano KM, Audu ML, Triolo RJ. Automatic application of neural stimulation during wheelchair propulsion after SCI enhances recovery of upright sitting from destabilizing events. J Neuroeng Rehabil. 2018 Mar 12;15(1):17. doi: 10.1186/s12984-018-0362-2.

Results Reference

derived

PubMed Identifier

28899825

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.

Results Reference

derived

PubMed Identifier

23542776

Citation

Wu GA, Lombardo L, Triolo RJ, Bogie KM. The effects of combined trunk and gluteal neuromuscular electrical stimulation on posture and tissue health in spinal cord injury. PM R. 2013 Aug;5(8):688-96. doi: 10.1016/j.pmrj.2013.03.025. Epub 2013 Mar 28.

Results Reference

derived

PubMed Identifier

23500182

Citation

Triolo RJ, Bailey SN, Miller ME, Lombardo LM, Audu ML. Effects of stimulating hip and trunk muscles on seated stability, posture, and reach after spinal cord injury. Arch Phys Med Rehabil. 2013 Sep;94(9):1766-75. doi: 10.1016/j.apmr.2013.02.023. Epub 2013 Mar 13.

Results Reference

derived

Links:

URL

http://fescenter.org

Description

Cleveland FES center website

Learn more about this trial

A Neuroprosthesis for Seated Posture and Balance

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