NCT05863754 · MetroHealth Medical Center
Grasp-Release Assessment of a Networked Neuroprosthesis Device
(GRANND)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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), Flexor Digitorum Profundus (FDP), Pronator Quadratus (PQ), Extensor Carpi Ulnaris (ECU), Extensor Carpi Radialis Brevis (ECRB), Extensor Carpi Radialis Longus (ECRL), Flexor Carpi Ulnaris (FCU), Flexor Carpi Radialis (FCR), First Dorsal Interosseous(1DI), triceps,
- 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.
Exclusion criteria
- 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 the investigator;
- 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.
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 19, 2025 · Source of record for eligibility and locations