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Trunk Protocol: A Neuroprosthesis for Seated Posture and Balance

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT01474148
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
146
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: IRS-8 (8-Channel implanted stimulator-telemeter)
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Neuroprosthesis for Seated Posture and Balance
Actual Study Start Date :
Nov 30, 2011
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Neuroprosthesis

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.

Device: IRS-8 (8-Channel implanted stimulator-telemeter)
Surgical implantation of the 8-channel neuroprosthesis
Other Names:
  • Implanted Neuroprosthesis for Seated Posture and Balance, Trunk implanted electrical stimulation system, Implanted trunk control neuroprosthesis, Implanted FNS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility. [up to 36 months]

      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

    1. Design a simple position controller [Up to 36 months]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Louis Stokes VA Medical Center, Cleveland, OH Cleveland Ohio United States 44106

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Ronald Triolo, PhD, Louis Stokes VA Medical Center, Cleveland, OH

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT01474148
    Other Study ID Numbers:
    • A1204-R
    • IRB#07101-H36
    First Posted:
    Nov 18, 2011
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by VA Office of Research and Development
    paraplegia
    tetraplegia
    Spinal cord injured
    FES
    Additional relevant MeSH terms:
    Spinal Cord Injuries
    Paralysis
    Paraplegia
    Quadriplegia

    Study Results

    No Results Posted as of Feb 18, 2022