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Evaluation of an Advanced Lower Extremity Neuroprostheses (LE-IST)

Primary Purpose

Spinal Cord Injuries, Stroke, Paralysis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IST-16 (16-channel implanted stimulator-telemeter)
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Spinal Cord Injuries focused on measuring Neurologic disorders, Rare disease, Spinal cord injuries, Stroke, Paraplegia, Tetraplegia

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Low cervical or thoracic spinal cord injury (C6-T12) or other paralyzing condition
  • Skeletal maturity
  • Ability to understand and sign informed consents
  • Disability equivalent to ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing) or C (motor and sensory sparing)
  • Intact and electrically excitable lower motor neurons
  • Greater than 6 months since injury or onset
  • Range of motion within normal limits

Exclusion Criteria:

  • Pacemaker
  • Cardiac arrythmia
  • Pregnancy
  • Contractures of any major joint of upper or lower extremities
  • Uncontrolled seizure disorder
  • Obesity
  • Untreated substance abuse
  • Immunodeficiency
  • Frequent urinary tract infections
  • Presence of decubitis ulcers
  • Acute or chronic psychological problems
  • Acute orthopaedic problems
  • Pulmonary compromise
  • Renal compromise
  • Circulatory compromise
  • History of spontaneous fractures or insulin dependent diabetes

Sites / Locations

  • Louis Stokes Cleveland VA Medical CenterRecruiting
  • MetroHealth SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implant

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

Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge
Repeated measures of standing duration in minutes
Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge
Repeated measures of arm/leg loading measured in Kg
Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge
Repeated measures of walking distance in meters
Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge
Repeated measures of walking time in minutes

Secondary Outcome Measures

Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge
Repeated measures of standing reach in cm, and transfer height in cm

Full Information

First Posted
January 24, 2008
Last Updated
October 20, 2023
Sponsor
Case Western Reserve University
Collaborators
National Institutes of Health (NIH), US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00623389
Brief Title
Evaluation of an Advanced Lower Extremity Neuroprostheses
Acronym
LE-IST
Official Title
Evaluation of Advanced Lower Extremity Neuroprostheses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
National Institutes of Health (NIH), US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.
Detailed Description
Protocol Outline: Patents undergo surgery in which electrodes are implanted into muscles of the trunk and legs. Electrode leads are connected to an stimulator/telemeter. Following implantation, patients undergo training in standing, transfers and other advanced mobility skills using the functional electrical stimulation system. A prescribed course of exercise, functional training and rehabilitation with the implanted stimulation system, followed by laboratory assessments of strength, balance and functional abilities with and without the system, as well as the technical performance of the implanted components. Home-based training follows prior to discharge for home use of the system. Patients are followed at 6 and 12 months after discharge and then annually thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Stroke, Paralysis, Tetraplegia, Paraplegia
Keywords
Neurologic disorders, Rare disease, Spinal cord injuries, Stroke, Paraplegia, Tetraplegia

7. Study Design

Primary Purpose
Device Feasibility
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
Implant
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)
IST-16 (16-channel implanted stimulator-telemeter)
Intervention Description
Pre-surgical exercise with surface electrical stimulation, surgery including electrode insertion and IST-16 stimulator/telemeter implantation, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.
Primary Outcome Measure Information:
Title
Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge
Description
Repeated measures of standing duration in minutes
Time Frame
Change from immediately after intervention and 1 year after intervention
Title
Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge
Description
Repeated measures of arm/leg loading measured in Kg
Time Frame
Change from immediately after intervention and 1 year after intervention
Title
Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge
Description
Repeated measures of walking distance in meters
Time Frame
Change from immediately after intervention and 1 year after intervention
Title
Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge
Description
Repeated measures of walking time in minutes
Time Frame
Change from immediately after intervention and 1 year after intervention
Secondary Outcome Measure Information:
Title
Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge
Description
Repeated measures of standing reach in cm, and transfer height in cm
Time Frame
Change from immediately after intervention and 1 year after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Low cervical or thoracic spinal cord injury (C6-T12) or other paralyzing condition Skeletal maturity Ability to understand and sign informed consents Disability equivalent to ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing) or C (motor and sensory sparing) Intact and electrically excitable lower motor neurons Greater than 6 months since injury or onset Range of motion within normal limits Exclusion Criteria: Pacemaker Cardiac arrythmia Pregnancy Contractures of any major joint of upper or lower extremities Uncontrolled seizure disorder Obesity Untreated substance abuse Immunodeficiency Frequent urinary tract infections Presence of decubitis ulcers Acute or chronic psychological problems Acute orthopaedic problems Pulmonary compromise Renal compromise Circulatory compromise History of spontaneous fractures or insulin dependent diabetes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa M Lombardo, MPT
Phone
216-791-3800
Ext
64909
Email
lisa.lombardo2@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Maura Malenchek, PTA
Phone
216-791-3800
Ext
64989
Email
maura.malencheck@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald J Triolo, Ph.D.
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Musa L Audu, Ph.D.
Organizational Affiliation
Louis Stokes Cleveland VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Stokes Cleveland VA Medical Center
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
Maura Malenchek, PTA
Phone
216-791-3800
Ext
64989
Email
maura.malenchek@va.gov
Facility Name
MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
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
64909
Email
lisa.lombardo2@va.gov
First Name & Middle Initial & Last Name & Degree
Maura Malenchek, PTA
Phone
216-791-3800
Ext
64989
Email
maura.malenchek@va.gov
First Name & Middle Initial & Last Name & Degree
Ronald J Triolo, Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
17946304
Citation
Dutta A, Kobetic R, Triolo RJ. Ambulation after incomplete spinal cord injury with electromyogram-triggered functional electrical stimulation. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:5408-11. doi: 10.1109/IEMBS.2006.259257.
Results Reference
background
PubMed Identifier
15218941
Citation
Uhlir JP, Triolo RJ, Davis JA Jr, Bieri C. Performance of epimysial stimulating electrodes in the lower extremities of individuals with spinal cord injury. IEEE Trans Neural Syst Rehabil Eng. 2004 Jun;12(2):279-87. doi: 10.1109/TNSRE.2004.827224.
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
14582528
Citation
Agarwal S, Triolo RJ, Kobetic R, Miller M, Bieri C, Kukke S, Rohde L, Davis JA Jr. Long-term user perceptions of an implanted neuroprosthesis for exercise, standing, and transfers after spinal cord injury. J Rehabil Res Dev. 2003 May-Jun;40(3):241-52.
Results Reference
background
PubMed Identifier
11767968
Citation
Davis JA Jr, Triolo RJ, Uhlir J, Bieri C, Rohde L, Lissy D, Kukke S. Preliminary performance of a surgically implanted neuroprosthesis for standing and transfers--where do we stand? J Rehabil Res Dev. 2001 Nov-Dec;38(6):609-17.
Results Reference
background
PubMed Identifier
17947042
Citation
Fisher LE, Miller ME, Nogan SJ, Davis JA, Anderson JS, Murray LM, Tyler DJ, Triolo RJ. Preliminary evaluation of a neural prosthesis for standing after spinal cord injury with four contact nerve-cuff electrodes for quadriceps stimulation. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:3592-5. doi: 10.1109/IEMBS.2006.260833.
Results Reference
result
PubMed Identifier
17873417
Citation
Mushahwar VK, Jacobs PL, Normann RA, Triolo RJ, Kleitman N. New functional electrical stimulation approaches to standing and walking. J Neural Eng. 2007 Sep;4(3):S181-97. doi: 10.1088/1741-2560/4/3/S05. Epub 2007 Aug 22.
Results Reference
result
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

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Evaluation of an Advanced Lower Extremity Neuroprostheses

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