Spinal Cord Injury at C5-C7 LevelGRANNDNCT05863754
Grasp-Release Assessment of a Networked Neuroprosthesis Device
A study testing Networked Neuroprosthesis Device in people with Spinal Cord Injury at C5-C7 Level and Spinal Cord Injuries, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injury at C5-C7 Level, Spinal Cord Injuries, Spinal Cord Injury Cervical
- What is being tested?
- Networked Neuroprosthesis Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2022to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
Anne Bryden, Ph.D, OTR/L, 216-957-3594, anne.bryden@case.edu
About this study
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.
Read the detailed description
The Networked Neuroprosthesis(NNP) is an implantable, configurable neuromodulation platform that provides functional movement by the coordinated activation of peripheral neural pathways activating innervated paralyzed muscles, and sensing of physiological signals. The NNP-UE Configuration activates nerves of the upper extremity (arm and hand), and senses voluntary motion and/or electromyogram (EMG) in order to provide hand grasp.
The proposed work is focused on restoration of hand and reaching functions for people with cervical level spinal cord injury. For individuals who have sustained this injury, restoration of hand function is their top priority, and existing alternatives are limited. Neuroprosthesis are the most promising method for significant gain in hand and arm function.
- Being tested
- Networked Neuroprosthesis Device
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Networked Neuroprosthesis DeviceDevice
The Networked Neuroprosthesis Device is an implantable, configurable neuromodulation platform that provides functional movement by the coordinated activation of peripheral neural pathways activating innervated paralyzed muscles, and sensing of physiological signals.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention - implant neuroprosthesis | Experimental | Receives implanted networked neuroprosthetic system for arm and hand function. Undergoes functional training and assessment. Receives: Device: Networked Neuroprosthesis Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Grasp-Release Test
Ability to pick up, move, and release six standard objects
Measured: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Secondary outcomes (4)
Change in Grasp Dynameter(force)
Measure of muscular strength or the maximum force/tension generated by one's forearm muscles.
Measured: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Change in Canadian Occupational Performance Measure (COPM)
Evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time
Measured: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Change in Activities of Daily Living (ADL) Abilities Test
The Activities of Daily Living (ADL) profile uses both observation and interview to assess function in tasks completed in the personal, home, and community environments.
Measured: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Change in Spinal Cord Independence Measure III (SCIM-III)
The measure address three specific areas of function in patients with spinal cord injuries (SCI). It looks at self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and a patient's mobility abilities (bed and transfers and indoors/outdoors)
Measured: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start23 Jan 2022
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury at C5-C7 LevelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Case Western Reserve University
- Responsible party
- Principal investigator, Anne Bryden, MetroHealth Medical Center
- Investigators
- Anne Bryden, PhD, OTR/L, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863754
- Sponsor's protocol ID
- IRB20-00854
- Acronym
- GRANND
- Status last verified
- Aug 2025
- First submitted
- 28 Apr 2023
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ho CH, Triolo RJ, Elias AL, Kilgore KL, DiMarco AF, Bogie K, Vette AH, Audu ML, Kobetic R, Chang SR, Chan KM, Dukelow S, Bourbeau DJ, Brose SW, Gustafson KJ, Kiss ZH, Mushahwar VK. Functional electrical stimulation and spinal cord injury. Phys Med Rehabil Clin N Am. 2014 Aug;25(3):631-54, ix. doi: 10.1016/j.pmr.2014.05.001.
PubMed 25064792Peckham PH, Kilgore KL. Challenges and opportunities in restoring function after paralysis. IEEE Trans Biomed Eng. 2013 Mar;60(3):602-9. doi: 10.1109/TBME.2013.2245128. Epub 2013 Mar 7.
PubMed 23481680Makowski N, Campean A, Lambrecht J, Buckett J, Coburn J, Hart R, Miller M, Montague F, Crish T, Fu M, Kilgore K, Peckham PH, Smith B. Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System. IEEE Trans Biomed Circuits Syst. 2021 Apr;15(2):281-293. doi: 10.1109/TBCAS.2021.3066838. Epub 2021 May 25.
PubMed 33729949
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grasp-Release Assessment of a Networked Neuroprosthesis Device
- ClinicalTrials.gov ID
- NCT05863754
- Acronym / sponsor ID
- GRANND / IRB20-00854
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Case Western Reserve University
- Study start
- 23 Jan 2022 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Networked Neuroprosthesis(NNP) is an implantable, configurable neuromodulation platform that provides functional movement by the coordinated activation of peripheral neural pathways activating innervated paralyzed muscles, and sensing of physiological signals. The NNP-UE Configuration activates nerves of the upper extremity (arm and hand), and senses voluntary motion and/or electromyogram (EMG) in order to provide hand grasp.
The proposed work is focused on restoration of hand and reaching functions for people with cervical level spinal cord injury. For individuals who have sustained this injury, restoration of hand function is their top priority, and existing alternatives are limited. Neuroprosthesis are the most promising method for significant gain in hand and arm function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention - implant neuroprosthesis | Experimental | Device: Networked Neuroprosthesis DeviceReceives implanted networked neuroprosthetic system for arm and hand function. Undergoes functional training and assessment. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, age > 16 years.
- Cervical level spinal cord injury, as defined by:
- 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).
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Networked Neuroprosthesis DeviceThe Networked Neuroprosthesis Device is an implantable, configurable neuromodulation platform that provides functional movement by the coordinated activation of peripheral neural pathways activating innervated paralyzed muscles, and sensing of physiological signals. | Device | Experimental: Intervention - implant neuroprosthesis |
Primary outcome
Change in Grasp-Release Test
Time frame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Ability to pick up, move, and release six standard objects
4 secondary outcomes
Change in Grasp Dynameter(force)
Time frame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Change in Canadian Occupational Performance Measure (COPM)
Time frame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Change in Activities of Daily Living (ADL) Abilities Test
Time frame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Change in Spinal Cord Independence Measure III (SCIM-III)
Time frame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 25064792Ho CH, Triolo RJ, Elias AL, Kilgore KL, DiMarco AF, Bogie K, Vette AH, Audu ML, Kobetic R, Chang SR, Chan KM, Dukelow S, Bourbeau DJ, Brose SW, Gustafson KJ, Kiss ZH, Mushahwar VK. Functional electrical stimulation and spinal cord injury. Phys Med Rehabil Clin N Am. 2014 Aug;25(3):631-54, ix. doi: 10.1016/j.pmr.2014.05.001.
- Background: PubMed 23481680Peckham PH, Kilgore KL. Challenges and opportunities in restoring function after paralysis. IEEE Trans Biomed Eng. 2013 Mar;60(3):602-9. doi: 10.1109/TBME.2013.2245128. Epub 2013 Mar 7.
- Background: PubMed 33729949Makowski N, Campean A, Lambrecht J, Buckett J, Coburn J, Hart R, Miller M, Montague F, Crish T, Fu M, Kilgore K, Peckham PH, Smith B. Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System. IEEE Trans Biomed Circuits Syst. 2021 Apr;15(2):281-293. doi: 10.1109/TBCAS.2021.3066838. Epub 2021 May 25.
- Cleveland Functional Electrical Stimulation CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Bryden, PhD, OTR/L principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Networked Neuroprosthesis Device in people with Spinal Cord Injury at C5-C7 Level and Spinal Cord Injuries, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KIm Walsh, OTR/L (216-957-3512, kwalsh3@metrohealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Grasp-Release Test (time frame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05863754, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.