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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)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
November 8, 2011
Last Updated
January 5, 2023
Sponsor
VA Office of Research and Development
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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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

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
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.
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
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.
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Design a simple position controller
Description
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)
Time Frame
Up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Email
Lisa.Lombardo2@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Emily C Johnson, BA
Phone
(216) 791-3800
Ext
64904
Email
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
Email
Lisa.Lombardo2@va.gov
First Name & Middle Initial & Last Name & Degree
Ronald Triolo, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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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