A Neuroprosthesis for Seated Posture and Balance (Trunk Protocol)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Case Western Reserve University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ronald J. Triolo, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01474148
First received: November 8, 2011
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Spinal Cord Injury
Paralysis
Tetraplegia
Paraplegia
Device: IRS-8 (8-Channel implanted stimulator-telemeter)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Neuroprosthesis for Seated Posture and Balance

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility. [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 10
Study Start Date: July 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • 1.)Implanted Neuroprosthesis for Seated Posture and Balance
  • 2.) Trunk implanted electrical stimulation system
  • 3.) Implanted trunk control neuroprosthesis
  • 4.) Implanted FNS trunk control

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 21
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474148

Contacts
Contact: Lisa M Lombardo, MPT 216-791-3800 ext 4909 llombardo@fescenter.org
Contact: Marilyn J McCormick, RN 216-791-3800 ext 4236 marilyn.mccormick@va.gov

Locations
United States, Ohio
Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lisa M Lombardo, MPT    216-791-3800 ext 4909    llombardo@fescenter.org   
Contact: Marilyn J McCormick, RN    216-791-3800 ext 4236    marilyn.mccormick@va.gov   
Principal Investigator: Ronald J Triolo, Ph.D         
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Ronald J Triolo, Ph.D. Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ronald J. Triolo, Director Advanced Platform Technology Center, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01474148     History of Changes
Other Study ID Numbers: IRB#07101-H36
Study First Received: November 8, 2011
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Western Reserve University:
paraplegia
tetraplegia
Spinal cord injured
FES

Additional relevant MeSH terms:
Paraplegia
Quadriplegia
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014