Actively Recruiting

Phase Not Applicable
Age: 17Years +
All Genders
NCT02329652

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

Led by Anne Bryden · Updated on 2025-12-19

30

Participants Needed

1

Research Sites

891 weeks

Total Duration

On this page

Sponsors

A

Anne Bryden

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 17Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of cervical level spinal cord injury, complete or incomplete, with motor level C4 through C8 and AIS grade A, B, C, or D, at least six months post-injury
  • Muscle strength of 2/5 or higher in biceps/brachialis/brachioradialis on Manual Muscle Test
  • Peripheral nerve innervation with stimulated muscle strength of grade 3/5 or higher in at least two specified muscles in one arm and two specified trunk muscles
  • Age over 16 years
  • Medically stable and cleared for surgery
  • Able and willing to participate in the study
Not Eligible

You will not qualify if you...

  • Currently pregnant (implantation delayed until no longer pregnant)
  • Other neurological conditions such as multiple sclerosis or diabetes with peripheral nerve involvement
  • History of coagulopathy, HIV, severe cardiopulmonary diseases, severe bradycardia, severe autonomic dysreflexia, or chronic obstructive pulmonary disease
  • Active untreated infections like decubitus ulcer, urinary tract infection, or pneumonia
  • Presence of other active implantable medical devices with unknown or untested interaction with the neuroprosthesis implant
  • Active implantable devices such as pacemakers or defibrillators, except specific implanted stimulator-telemeter or receiver stimulator systems
  • Unhealed fractures preventing functional use of arm or trunk
  • Less than six months post-injury (implantation delayed)
  • Extensive upper extremity denervation with fewer than two stimulatable hand and trunk muscles
  • Participation in other ongoing clinical studies that exclude concurrent involvement
  • Conditions requiring MRI monitoring
  • Dependence on mechanical ventilator
  • Progressive spinal cord injury
  • History of autonomic dysreflexia, hypertension, diabetes, or conditions requiring frequent blood pressure or venipuncture monitoring for those undergoing bilateral implantation
  • Adverse interactions with electromagnetic sources in home or work environment including active implantable devices like wheelchairs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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