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New treatment option for Spinal Cord Injuries
Official title Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury
ClinicalTrials.gov ID: NCT02329652
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 17 and older
You may be able to join if
- Diagnosis of cervical level spinal cord injury, either complete or incomplete; International Standards for Neurological Classification of Spinal Cord...
- Biceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Test
- Peripheral nerve innervation to upper extremity and trunk muscles, including a grade 3/5 or higher stimulated strength (Manual Muscle Test) in at...
- Age \> 16 years
- Medically stable - cleared for surgery
You likely can't join if
- Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant)
- Other neurological conditions (multiple sclerosis, diabetes with peripheral nerve involvement)
- History of coagulopathy, HIV, severe cardiopulmonary disease, severe bradycardia, severe autonomic dysreflexia, or chronic obstructive pulmonary...
- Active untreated infection such as decubitus ulcer, urinary tract infection, pneumonia
- Presence of other active implantable medical devices with unknown or untested interaction with the NNP implant
- Active implantable medical device (AIMD) such as a pacemaker or defibrillator, with the exception of the implanted stimulator-telemeter (IST) or...
See the full eligibility criteria
- 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...
- Biceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Test
- 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...
- Age \> 16 years
- Medically stable - cleared for surgery
- Able and willing to take part in study
- Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant)
- Other neurological conditions (multiple sclerosis, diabetes with peripheral nerve involvement)
- History of coagulopathy, HIV, severe cardiopulmonary disease, severe bradycardia, severe autonomic dysreflexia, or chronic obstructive pulmonary disease.
- Active untreated infection such as decubitus ulcer, urinary tract infection, pneumonia
- Presence of other active implantable medical devices with unknown or untested interaction with the NNP implant
- 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...
- Unhealed fractures that prevent functional use of arm or trunk
- Less than six months post-injury (neuroprosthesis implantation delayed until criteria met)
- Extensive upper extremity denervation (fewer than two stimulatable hand muscles and two stimulatable trunk muscles)
- Involvement in other ongoing clinical studies that exclude concurrent until criteria met)
- Disorder or condition that require MRI monitoring
- Mechanical ventilator dependency
- Progressive SCI In people who are undergoing bilateral implantation, people should not have a history of autonomic dysreflexia, hypertension, diabetes or any condition which requires frequent blood pressure monitoring...
- Adverse interaction between system components and typical electromagnetic (EM) sources in subject's home and work environments, including wheelchair or other active implantable devices.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 17 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.