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Thread: Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries

  1. #1

    Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries

    http://clinicaltrials.gov/ct/gui/c/a1b/show/NCT00004445?order=1&JServSessionId zone_ct=ytqjceg4j1

    Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries

    This study is currently recruiting patients.

    Sponsored by

    FDA Office of Orphan Products Development Case Western Reserve University

    Purpose


    OBJECTIVES: I. Establish the procedures for implementing and assessing the clinical utility of functional neuromuscular stimulation using an implanted eight-channel standing and transfer system in patients with incomplete tetraplegia or paraplegia.

    II. Develop and apply quantitative functional evaluations of system performance in these patients.

    III. Perform long term follow up and monitor system use outside of the laboratory.


    Condition
    spinal cord injury


    MEDLINEplusrelated topics:SpinalCordInjuries

    Study Type:Treatment


    Further Study Details:


    PROTOCOL OUTLINE: Patients undergo surgery in which electrodes are sutured into areas of the pelvis and legs. Electrode leads are inserted into a receiver/stimulator implanted in a subcutaneous pocket in the abdomen. Following implantation, patients undergo training in standing, transfers, and other advanced mobility skills using the functional neuromuscular stimulation system. Restricted activity continues for 2 weeks after surgery, followed by 8 weeks of exercise. Standing training then begins, and continues for up to 6 weeks. Home-based training follows prior to discharge with the system for spontaneous use.

    Patients are followed at 3, 6, and 12 months, then annually thereafter.


    PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study within 2 years.

    Eligibility

    Ages Eligible for Study: 18 Years and above

    Criteria


    PROTOCOL ENTRY CRITERIA:

    --Disease Characteristics--

    Low cervical or thoracic spinal cord injuries (C6-T12)

    Must be skeletally mature

    ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing), or C (motor and sensory sparing)

    Intact lower motor neurons

    Greater than 6 months since injury

    Range of motion within normal limits

    --Prior/Concurrent Therapy--

    Not specified

    -Patient Characteristics--

    Age: 18 and over

    Performance status: Not specified

    Hematopoietic: Not specified

    Hepatic: Not specified

    Renal: No renal compromise

    Cardiovascular: No cardiac abnormalities No circulatory compromise

    Pulmonary: No pulmonary compromise

    Other: No acute or chronic psychological problems or chemical dependency No acute orthopedic complications (scoliosis, history of spontaneous fractures, dislocations, etc.) No acute medical complications (no skin breakdowns, uncontrolled seizures, immunological compromise, etc.)

    Location and Contact Information

    Ohio
    Case Western Reserve University,Cleveland, Ohio, 44106, United States;Recruiting

    Ronald J. Triolo 216-778-7877

    Ohio
    MetroHealth System,Cleveland, Ohio, 44109, United States;Recruiting

    John A. Davis 216-778-3456

    Study chairs or principal investigators

    Ronald J. Triolo, Study Chair
    Case Western Reserve University


    More Information

    More information is available for this study.

    Study ID Numbers 199/13455; CWRU-FDR001244 NLM Identifier NCT00004445

    Date study startedSeptember 29, 1996

    Last Updated May 1, 1999

    [This message was edited by Wise Young on August 06, 2001 at 12:45 PM.]

  2. #2
    From Max:

    Topic: Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries in Clinical Trials Edit Message
    by Max on Jun 03, 2002 at 07:01 PM from IP 216.209.61.246
    Moderation reason: Forum moderation settings.

    Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries
    This study is currently recruiting patients.
    Sponsored by
    FDA Office of Orphan Products Development
    Case Western Reserve University
    Purpose
    OBJECTIVES: I. Establish the procedures for implementing and assessing the clinical utility of functional neuromuscular stimulation using an implanted eight-channel standing and transfer system in patients with incomplete tetraplegia or paraplegia. II. Develop and apply quantitative functional evaluations of system performance in these patients. III. Perform long term follow up and monitor system use outside of the laboratory.
    Condition Treatment or Intervention
    Spinal Cord Injury Procedure: Surgery
    MEDLINEplus related topics: Spinal Cord Injuries
    Study Type: Interventional
    Study Design: Treatment, Non-Randomized
    Further Study Details:
    PROTOCOL OUTLINE: Patients undergo surgery in which electrodes are sutured into areas of the pelvis and legs. Electrode leads are inserted into a receiver/stimulator implanted in a subcutaneous pocket in the abdomen. Following implantation, patients undergo training in standing, transfers, and other advanced mobility skills using the functional neuromuscular stimulation system. Restricted activity continues for 2 weeks after surgery, followed by 8 weeks of exercise. Standing training then begins, and continues for up to 6 weeks. Home-based training follows prior to discharge with the system for spontaneous use. Patients are followed at 3, 6, and 12 months, then annually thereafter.
    Eligibility
    Ages Eligible for Study: 18 Years and above , Genders Eligible for Study: Both
    Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Low cervical or thoracic spinal cord injuries (C6-T12) Must be skeletally mature ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing), or C (motor and sensory sparing) Intact lower motor neurons Greater than 6 months since injury Range of motion within normal limits --Patient Characteristics-- Renal: No renal compromise Cardiovascular: No cardiac abnormalities No circulatory compromise Pulmonary: No pulmonary compromise Other: No acute or chronic psychological problems or chemical dependency No acute orthopedic complications (scoliosis, history of spontaneous fractures, dislocations, etc.) No acute medical complications (no skin breakdowns, uncontrolled seizures, immunological compromise, etc.)
    Expected Total Enrollment: 17
    Location and Contact Information
    Ohio
    Case Western Reserve University, Cleveland, Ohio, 44106, United States; Recruiting
    Ronald J. Triolo 216-778-7877
    Ohio
    MetroHealth System, Cleveland, Ohio, 44109, United States; Recruiting
    John A. Davis 216-778-3456
    Study chairs or principal investigators
    Ronald J. Triolo, Study Chair
    Case Western Reserve University
    More Information
    Study ID Numbers 199/13455; CWRU-FDR001244
    Date study started September 1996
    Record last reviewed May 1999
    NLM Identifier NCT00004445
    ClinicalTrials.gov processed this record on 2002-05-24

  3. #3
    Senior Member giambjj's Avatar
    Join Date
    Jul 2001
    Location
    Auburn, AL,USA
    Posts
    1,866

    implants

    These studies have been gone on over the past year at the Schriners Hospital in Philly. Saw some nice results first hand. It is a good start, however, the kids movements are very robotic and ackward!

    JJG

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