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New treatment option for Spinal Cord Injury at C5-C7 Level
Official title Grasp-Release Assessment of a Networked Neuroprosthesis Device
ClinicalTrials.gov ID: NCT05863754
What this study is testing
- What it's testing
- The overall objective of this trial is to characterize the safety and effectiveness of the Networked Neuroprosthesis Device - Upper Extremity (NP-UE) in individuals living with cervical SCI.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Male or female, age \> 16 years.
- Cervical level spinal cord injury, as defined by:
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor level of C1 through C7 and
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B, or C;
- Six months or more post-injury (neurostability);
You likely can't join if
- Other neurological conditions (MS(multiple Sclerosis), diabetes with peripheral nerve involvement); Associated peripheral nerve / brachial plexus...
- Progressive SCI;
- Co-existing cervical spine pathology (syrinx, unstable segment)
- Active implantable medical device (AIMD) such as a pacemaker or defibrillator;
- Active untreated infection such as pressure injury, urinary tract infection, pneumonia;
- History of coagulopathy, HIV, cardiopulmonary disease, bradycardia, poorly controlled autonomic dysreflexia, or chronic obstructive pulmonary disease...
See the full eligibility criteria
- Male or female, age \> 16 years.
- Cervical level spinal cord injury, as defined by:
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor level of C1 through C7 and
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B, or C;
- Six months or more post-injury (neurostability);
- Neurologically stable following any nerve transfers affecting the upper extremity (typically, one year post surgery);
- Musculoskeletally and neurologically stable following any tendon transfers affecting the upper extremity (typically, 6-months).
- Peripheral nerve innervation to upper extremity muscles, including a grade 3/5 or higher Stimulated Manual Muscle Test (SMMT) strength in at least two of the following muscles in one arm:
- Adductor Pollicus, Abductor Pollicus Brevis (AbPB), Flexor Pollicus Longus (FPL), Extensor Pollicus Longus (EPL)/Extensor Pollicus Brevis (EPB), Extensor Digitorum Communis (EDC), Flexor Digitorum Superficialis (FDS)...
- At least two of the grade 3/5 or higher excitable muscles must also have grade 2/5 or lower voluntary strength;
- Good proximal upper extremity strength as defined by biceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Test on the side intended for implantation;
- Medically stable;
- Able to understand and provide informed consent.
- Other neurological conditions (MS(multiple Sclerosis), diabetes with peripheral nerve involvement); Associated peripheral nerve / brachial plexus injury
- Progressive SCI;
- Co-existing cervical spine pathology (syrinx, unstable segment)
- Active implantable medical device (AIMD) such as a pacemaker or defibrillator;
- Active untreated infection such as pressure injury, urinary tract infection, pneumonia;
- History of coagulopathy, HIV, cardiopulmonary disease, bradycardia, poorly controlled autonomic dysreflexia, or chronic obstructive pulmonary disease that would preclude safe participation in the trial as determined by...
- Unhealed fractures that prevent functional use of arm;
- Extensive upper extremity denervation (fewer than two excitable hand muscles);
- Involvement in other ongoing clinical studies that exclude concurrent involvement in this study;
- Disorder or condition that requires MRI monitoring;
- Mechanical ventilator dependency;
- Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant);
- Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
- Other significant medical findings that, in the opinion of the investigator, preclude safe participation in the trial.
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, 16 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.