Spinal Cord InjuriesNNP-UE+TNCT02329652
Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury
A study testing Networked Neuroprosthetic System for Grasp and Trunk in people with Spinal Cord Injuries and Spinal Cord Injury at C5-C7 Level, run by Anne Bryden at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Injury at C5-C7 Level, Spinal Cord Injury Cervical
- What is being tested?
- Networked Neuroprosthetic System for Grasp and Trunk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2014to 31 Dec 2031
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 Impairment Scale (AIS) grade A, B, C, or D; six months or more post-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, abductor pollicis brevis, flexor pollicis longus, extensor pollicis longus, extensor digitorum communis, flexor digitorum superficialis, flexor digitorum profundus, pronator quadratus, extensor carpi ulnaris, extensor carpi radialis brevis, extensor radialis longus, flexor carpi ulnaris, flexor carpi radialis, first dorsal interosseous; and in at least two of the following muscles: left/right gluteus maximus, left/right erector spinae, left/right quadratus lumborum,
- Age > 16 years
- Medically stable - cleared for surgery
- Able and willing to take part in study
Who cannot join
- 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 Functional Electrical Stimulation Center
Show all 14Show fewer
- 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 subjects who are undergoing bilateral implantation, subjects should not have a history of autonomic dysreflexia, hypertension, diabetes or any condition which requires frequent blood pressure monitoring or frequent venipuncture.
- Adverse interaction between system components and typical electromagnetic (EM) sources in subject's home and work environments, including wheelchair or other active implantable devices.
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 L Byrden, Ph.D., UE.FES.ClinicalTrials@gmail.com
Anne L Bryden, Ph.D.
About this study
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
Read the detailed description
The goal of this project is to restore these multiple functions to these individuals through a comprehensive neuroprosthetic approach that addresses the overall needs of the individual. This approach involves all aspects of the implementation, including the implanted technology, the surgical installation, and the outcomes assessment through a coordinated team approach in order to maximize the functional independence gained by the individual. With this system, we propose that individuals who have a mid-cervical-level spinal cord injury will regain control over multiple functions, including grasp, reach, bed mobility, seated posture, restoration of an effective cough and bladder function. This ambitious and exciting goal is made possible by the culmination of our research and clinical deployment of neuroprosthetic systems for spinal cord injured subjects over the past 30 years. We anticipate that this system will not only provide increased independence in each of the targeted body functions, but will provide enough of an overall benefit to demonstrate significant improvements in quality of life and health outcomes.
In clinical feasibility studies with spinal cord injured subjects, our clinical research teams have demonstrated the control of bilateral hand function, bed mobility, postural control, restoration of an effective cough, and bladder control using chronically implanted neuroprostheses. Outcomes from each clinical study demonstrate that each system provides increased functional independence to the individual. Initially, only a single type of implanted system was implemented in any one individual, resulting in restoration of a single bodily function. Thus, it has been necessary for subjects to choose between available functions and select only one, despite the fact that each subject had multiple disabilities. In the past few years, we have progressed to implementing a few subjects with more than one system, such as providing both hand function and trunk stability. However, the fundamental limitation of the current approach has been technological; i.e. each implanted system is completely independent (both technically and programmatically), requiring separate technology to be developed for each function, and these systems are implemented by separate teams in separate surgical procedures. Thus, to this point, it has not been possible to address each individual's comprehensive needs and tailor an overall approach that maximizes their functional gains.
The proposed approach depends on the availability of a foundational platform technology that is capable of meeting our broad specifications. We have now achieved this milestone under separate funding, creating a revolutionary new implantable neuroprosthetic technology that is fully capable of providing the necessary technological base for our proposed research. This system, the Networked Neuroprosthetic System (NNPS), is a modular, scalable, and configurable network of fully implanted, networked modules capable of meeting or exceeding the needs of all of these neuroprosthetic applications. The NNPS provides a foundation which enables efficient technical refinements that optimize implementation of the system for each targeted application. The NNPS technology is currently operational and is undergoing fabrication and testing in preparation for final pre-clinical studies and human implantation.
- Conditions
- Spinal Cord Injuries, Spinal Cord Injury at C5-C7 Level, Spinal Cord Injury Cervical, Spinal Cord Injury at C5-C7 Level With Complete Lesion, Spinal Cord Injury at C5-C7 Level With Incomplete Lesion
- Being tested
- Networked Neuroprosthetic System for Grasp and Trunk
- Keywords
- Neuroprosthesis, Functional Electrical Stimulation, Grasp, Posture, Standing, Function, Recovery, Device, Stimulation, Implant, Reach, Independence, Activities of Daily Living
- 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 Neuroprosthetic System for Grasp and TrunkDevice
Receive implanted networked neuroprosthesis
| Study group | Role | What they receive |
|---|---|---|
| Intervention - implant neuroprosthesis | Experimental | Receives implanted networked neuroprosthetic system for hand, arm, and trunk function. Undergoes functional training and assessment. Receives: Device: Networked Neuroprosthetic System for Grasp and Trunk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities of Daily Living Abilities Test
Evaluation of ability to perform activities of daily living when using the neuroprosthesis compared to ability when the neuroprosthesis is turned off.
Measured: Three months post-implant
Secondary outcomes (1)
Grasp-Release Test
Ability to pick up, move, and release six standard objects.
Measured: Pre-implant and three 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 posted31 Dec 2014 (estimated)
- Study start1 Dec 2014
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne Bryden
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Case Western Reserve University, Congressionally Directed Medical Research Programs, FDA Orphan Products Division
- Responsible party
- Sponsor-investigator, Anne Bryden, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329652
- Sponsor's protocol ID
- NNP-UE+T
- Other IDs
- U01NS069517, UH2NS103863, OPD #5409, CDMRP-SC090230
- Acronym
- NNP-UE+T
- Status last verified
- Oct 2025
- First submitted
- 29 Dec 2014
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 33729949Kilgore KL, Hoyen HA, Bryden AM, Hart RL, Keith MW, Peckham PH. An implanted upper-extremity neuroprosthesis using myoelectric control. J Hand Surg Am. 2008 Apr;33(4):539-50. doi: 10.1016/j.jhsa.2008.01.007.
PubMed 18406958
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
- Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02329652
- Acronym / sponsor ID
- NNP-UE+T / NNP-UE+T
- Conditions
- Spinal Cord Injuries, Spinal Cord Injury at C5-C7 Level, Spinal Cord Injury Cervical, Spinal Cord Injury at C5-C7 Level With Complete Lesion, Spinal Cord Injury at C5-C7 Level With Incomplete Lesion
- Keywords
- Neuroprosthesis, Functional Electrical Stimulation, Grasp, Posture, Standing, Function, Recovery, Device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anne BrydenUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Case Western Reserve University, Congressionally Directed Medical Research Programs, FDA Orphan Products Division
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 31 Dec 2014 (estimated)
- 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.
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
Detailed description
The goal of this project is to restore these multiple functions to these individuals through a comprehensive neuroprosthetic approach that addresses the overall needs of the individual. This approach involves all aspects of the implementation, including the implanted technology, the surgical installation, and the outcomes assessment through a coordinated team approach in order to maximize the functional independence gained by the individual. With this system, we propose that individuals who have a mid-cervical-level spinal cord injury will regain control over multiple functions, including grasp, reach, bed mobility, seated posture, restoration of an effective cough and bladder function. This ambitious and exciting goal is made possible by the culmination of our research and clinical deployment of neuroprosthetic systems for spinal cord injured subjects over the past 30 years. We anticipate that this system will not only provide increased independence in each of the targeted body functions, but will provide enough of an overall benefit to demonstrate significant improvements in quality of life and health outcomes.
In clinical feasibility studies with spinal cord injured subjects, our clinical research teams have demonstrated the control of bilateral hand function, bed mobility, postural control, restoration of an effective cough, and bladder control using chronically implanted neuroprostheses. Outcomes from each clinical study demonstrate that each system provides increased functional independence to the individual. Initially, only a single type of implanted system was implemented in any one individual, resulting in restoration of a single bodily function. Thus, it has been necessary for subjects to choose between available functions and select only one, despite the fact that each subject had multiple disabilities. In the past few years, we have progressed to implementing a few subjects with more than one system, such as providing both hand function and trunk stability. However, the fundamental limitation of the current approach has been technological; i.e. each implanted system is completely independent (both technically and programmatically), requiring separate technology to be developed for each function, and these systems are implemented by separate teams in separate surgical procedures. Thus, to this point, it has not been possible to address each individual's comprehensive needs and tailor an overall approach that maximizes their functional gains.
The proposed approach depends on the availability of a foundational platform technology that is capable of meeting our broad specifications. We have now achieved this milestone under separate funding, creating a revolutionary new implantable neuroprosthetic technology that is fully capable of providing the necessary technological base for our proposed research. This system, the Networked Neuroprosthetic System (NNPS), is a modular, scalable, and configurable network of fully implanted, networked modules capable of meeting or exceeding the needs of all of these neuroprosthetic applications. The NNPS provides a foundation which enables efficient technical refinements that optimize implementation of the system for each targeted application. The NNPS technology is currently operational and is undergoing fabrication and testing in preparation for final pre-clinical studies and human implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention - implant neuroprosthesis | Experimental | Device: Networked Neuroprosthetic System for Grasp and TrunkReceives implanted networked neuroprosthetic system for hand, arm, and trunk function. Undergoes functional training and assessment. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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 Impairment Scale (AIS) grade A, B, C, or D; six months or more post-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, abductor pollicis brevis, flexor pollicis longus, extensor pollicis longus, extensor digitorum communis, flexor digitorum superficialis, flexor digitorum profundus, pronator quadratus, extensor carpi ulnaris, extensor carpi radialis brevis, extensor radialis longus, flexor carpi ulnaris, flexor carpi radialis, first dorsal interosseous; and in at least two of the following muscles: left/right gluteus maximus, left/right erector spinae, left/right quadratus lumborum,
- Age > 16 years
- Medically stable - cleared for surgery
Key exclusion criteria (14 listed)
- 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
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 Neuroprosthetic System for Grasp and TrunkReceive implanted networked neuroprosthesis | Device | Intervention - implant neuroprosthesis |
Primary outcome
Activities of Daily Living Abilities Test
Time frame: Three months post-implant
Evaluation of ability to perform activities of daily living when using the neuroprosthesis compared to ability when the neuroprosthesis is turned off.
1 secondary outcome
Grasp-Release Test
Time frame: Pre-implant and three 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.
- Results publication: PubMed 18406958Kilgore KL, Hoyen HA, Bryden AM, Hart RL, Keith MW, Peckham PH. An implanted upper-extremity neuroprosthesis using myoelectric control. J Hand Surg Am. 2008 Apr;33(4):539-50. doi: 10.1016/j.jhsa.2008.01.007.
- Cleveland Functional Electrical Stimulation CenterLink provided by the sponsor.
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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.
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 Neuroprosthetic System for Grasp and Trunk in people with Spinal Cord Injuries and Spinal Cord Injury at C5-C7 Level, run by Anne Bryden 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 6 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities of Daily Living Abilities Test (time frame: Three 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 NCT02329652, which also lists 4 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; AzTrials last refreshed its copy on 3 Nov 2026.