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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 21 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Implant 		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: IST-16 (16-channel implanted stimulator-telemeter)
    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.

Recruiting Locations

MetroHealth System
Cleveland, Ohio 44109
Contact:
Lisa M Lombardo, MPT
216-791-3800
lisa.lombardo2@va.gov

More Details

Status
Recruiting
Sponsor
Case Western Reserve University

Study Contact

Lisa M Lombardo, MPT
216-791-3800
lisa.lombardo2@va.gov

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.