RECRUITING

Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury

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Conditions

Spinal Cord InjuriesSpinal Cord Injury at C5-C7 LevelSpinal Cord Injury CervicalSpinal Cord Injury at C5-C7 Level With Complete LesionSpinal Cord Injury at C5-C7 Level With Incomplete LesionNeuroprosthesisFunctional Electrical StimulationGraspPostureStandingFunctionRecoveryDeviceStimulationImplantReachIndependenceActivities of Daily Living

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is to evaluate the use of a fully implanted device for providing hand function, reach, and trunk function to individuals with cervical spinal cord injury. Funding Sources: FDA OOPD NIH NINDS

Official Title

Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury

Quick Facts

Study Start:2014-12
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02329652

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of cervical level spinal cord injury, either complete or incomplete; International Standards for Neurological Classification of Spinal Cord Injury (INCSCI) motor level of C4 through C8; American Spinal Injury Impairment Scale (AIS) grade A, B, C, or D; six months or more post-injury
  2. * Biceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Test
  3. * Peripheral nerve innervation to upper extremity and trunk muscles, including a grade 3/5 or higher stimulated strength (Manual Muscle Test) in at least two of the following muscles in one arm: adductor pollicis, abductor pollicis brevis, flexor pollicis longus, extensor pollicis longus, extensor digitorum communis, flexor digitorum superficialis, flexor digitorum profundus, pronator quadratus, extensor carpi ulnaris, extensor carpi radialis brevis, extensor radialis longus, flexor carpi ulnaris, flexor carpi radialis, first dorsal interosseous; and in at least two of the following muscles: left/right gluteus maximus, left/right erector spinae, left/right quadratus lumborum,
  4. * Age \> 16 years
  5. * Medically stable - cleared for surgery
  6. * Able and willing to take part in study
  1. * Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant)
  2. * Other neurological conditions (multiple sclerosis, diabetes with peripheral nerve involvement)
  3. * History of coagulopathy, HIV, severe cardiopulmonary disease, severe bradycardia, severe autonomic dysreflexia, or chronic obstructive pulmonary disease.
  4. * Active untreated infection such as decubitus ulcer, urinary tract infection, pneumonia
  5. * Presence of other active implantable medical devices with unknown or untested interaction with the NNP implant
  6. * Active implantable medical device (AIMD) such as a pacemaker or defibrillator, with the exception of the implanted stimulator-telemeter (IST) or implanted receiver stimulator (IRS) systems developed by the Cleveland Functional Electrical Stimulation Center
  7. * Unhealed fractures that prevent functional use of arm or trunk
  8. * Less than six months post-injury (neuroprosthesis implantation delayed until criteria met)
  9. * Extensive upper extremity denervation (fewer than two stimulatable hand muscles and two stimulatable trunk muscles)
  10. * Involvement in other ongoing clinical studies that exclude concurrent until criteria met)
  11. * Disorder or condition that require MRI monitoring
  12. * Mechanical ventilator dependency
  13. * Progressive SCI In subjects who are undergoing bilateral implantation, subjects should not have a history of autonomic dysreflexia, hypertension, diabetes or any condition which requires frequent blood pressure monitoring or frequent venipuncture.
  14. * Adverse interaction between system components and typical electromagnetic (EM) sources in subject's home and work environments, including wheelchair or other active implantable devices.

Contacts and Locations

Study Locations (Sites)

MetroHealth Medical Center
Cleveland, Ohio, 44109
United States

Collaborators and Investigators

Sponsor: Kevin Kilgore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-12
Study Completion Date2030-12

Study Record Updates

Study Start Date2014-12
Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

  • Neuroprosthesis
  • Functional Electrical Stimulation
  • Grasp
  • Posture
  • Standing
  • Function
  • Recovery
  • Device
  • Stimulation
  • Implant
  • Reach
  • Independence
  • Activities of Daily Living

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Spinal Cord Injury at C5-C7 Level
  • Spinal Cord Injury Cervical
  • Spinal Cord Injury at C5-C7 Level With Complete Lesion
  • Spinal Cord Injury at C5-C7 Level With Incomplete Lesion