- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05863754
Grasp-Release Assessment of a Networked Neuroprosthesis Device (GRANND)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kristine Hansen, PT
- Phone Number: 216-957-3584
- Email: khansen1@metrohealth.org
Study Contact Backup
- Name: Anne Bryden, Ph.D, OTR/L
- Phone Number: 216-778-5347
- Email: anne.bryden@case.edu
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44109
- Recruiting
- MetroHealth Medical Center
-
Contact:
- Anne Bryden, Ph.D, OTR/L
- Phone Number: 216-957-3594
- Email: anne.bryden@case.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Intervention - implant neuroprosthesis
Receives implanted networked neuroprosthetic system for arm and hand function.
Undergoes functional training and assessment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Grasp Dynameter(force)
Time Frame: Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
|
Measure of muscular strength or the maximum force/tension generated by one's forearm muscles.
|
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
|
Evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time
|
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
|
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.
|
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
|
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)
|
Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne Bryden, PhD, OTR/L, MetroHealth Medical Center
Publications and helpful links
General 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.
- Peckham 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.
- Makowski 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB20-00854
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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