A Neuroprosthesis for Seated Posture and Balance

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Brief Title

A Neuroprosthesis for Seated Posture and Balance

Official Title

A Neuroprosthesis for Seated Posture and Balance

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.
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Design a simple position controller

Condition

Spinal Cord Injury

Intervention

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

Study Arms / Comparison Groups

 Neuroprosthesis
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

November 30, 2011

Completion Date

January 31, 2022

Primary Completion Date

January 31, 2022

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
      

Gender

All

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ronald Triolo, PhD, (216) 791-3800, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01474148

Organization ID

A1204-R

Secondary IDs

IRB#07101-H36

Responsible Party

Sponsor

Study Sponsor

VA Office of Research and Development


Study Sponsor

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


Verification Date

May 2021