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A Neuroprosthesis for Seated Posture and Balance (Trunk Protocol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01474148
Recruitment Status : Recruiting
First Posted : November 18, 2011
Last Update Posted : January 6, 2023
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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
Spinal Cord Injury Paralysis Tetraplegia Paraplegia Device: IRS-8 (8-Channel implanted stimulator-telemeter) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 30, 2011
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility. [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474148


Contacts
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Contact: Lisa M Lombardo, MPT (216) 791-3800 ext 4909 Lisa.Lombardo2@va.gov
Contact: Emily C Johnson, BA (216) 791-3800 ext 64904 emily.johnson17@va.gov

Locations
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United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lisa M Lombardo, MPT    216-791-3800 ext 4909    Lisa.Lombardo2@va.gov   
Principal Investigator: Ronald Triolo, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Ronald Triolo, PhD Louis Stokes VA Medical Center, Cleveland, OH
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01474148    
Other Study ID Numbers: A1204-R
IRB#07101-H36 ( Other Identifier: Case Western Reserve University )
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Spinal Cord Injuries
Paralysis
Paraplegia
Quadriplegia
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations