Evaluation of an Advanced Lower Extremity Neuroprostheses

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Brief Title

Evaluation of an Advanced Lower Extremity Neuroprostheses

Official Title

Evaluation of Advanced Lower Extremity Neuroprostheses

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.
    


Study Type

Interventional


Primary Outcome

Device reliability and technical performance measuring changes in standing from baseline at discharge to 12 months after discharge

Secondary Outcome

 Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge

Condition

Spinal Cord Injuries

Intervention

IST-16 (16-channel implanted stimulator-telemeter)

Study Arms / Comparison Groups

 A
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

June 1, 2018

Completion Date

May 31, 2025

Primary Completion Date

May 31, 2025

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
      

Gender

All

Ages

21 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Ronald J Triolo, Ph.D., 216-791-3800, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00623389

Organization ID

EB-001889

Secondary IDs

NS-040547

Responsible Party

Principal Investigator

Study Sponsor

Case Western Reserve University

Collaborators

 National Institutes of Health (NIH)

Study Sponsor

Ronald J Triolo, Ph.D., Principal Investigator, Case Western Reserve University


Verification Date

July 2021