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Grasp-Release Assessment of a Networked Neuroprosthesis Device (GRANND)

Primary Purpose

Spinal Cord Injury at C5-C7 Level, Spinal Cord Injuries, Spinal Cord Injury Cervical

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Networked Neuroprosthesis Device
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury at C5-C7 Level

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MetroHealth Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Intervention - implant neuroprosthesis

Arm Description

Receives implanted networked neuroprosthetic system for arm and hand function. Undergoes functional training and assessment.

Outcomes

Primary Outcome Measures

Change in Grasp-Release Test
Ability to pick up, move, and release six standard objects

Secondary Outcome Measures

Change in Grasp Dynameter(force)
Measure of muscular strength or the maximum force/tension generated by one's forearm muscles.
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
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.
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)

Full Information

First Posted
April 28, 2023
Last Updated
July 19, 2023
Sponsor
MetroHealth Medical Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT05863754
Brief Title
Grasp-Release Assessment of a Networked Neuroprosthesis Device
Acronym
GRANND
Official Title
Grasp-Release Assessment of a Networked Neuroprosthesis Device
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury at C5-C7 Level, Spinal Cord Injuries, Spinal Cord Injury Cervical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Intervention - implant neuroprosthesis
Arm Type
Experimental
Arm Description
Receives implanted networked neuroprosthetic system for arm and hand function. Undergoes functional training and assessment.
Intervention Type
Device
Intervention Name(s)
Networked Neuroprosthesis Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Grasp-Release Test
Description
Ability to pick up, move, and release six standard objects
Time Frame
Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Secondary Outcome Measure Information:
Title
Change in Grasp Dynameter(force)
Description
Measure of muscular strength or the maximum force/tension generated by one's forearm muscles.
Time Frame
Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Title
Change in Canadian Occupational Performance Measure (COPM)
Description
Evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time
Time Frame
Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Title
Change in Activities of Daily Living (ADL) Abilities Test
Description
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.
Time Frame
Pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Title
Change in Spinal Cord Independence Measure III (SCIM-III)
Description
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)
Time Frame
Pre-implant and three months post-implant, 6 months post implant, 12 months post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Bryden, Ph.D, OTR/L
Phone
216-778-5347
Email
anne.bryden@case.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristine Hansen, PT
Phone
216-957-3584
Email
khansen1@metrohealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Bryden, PhD, OTR/L
Organizational Affiliation
MetroHealth Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Bryden, Ph.D, OTR/L
Phone
216-957-3594
Email
anne.bryden@case.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25064792
Citation
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.
Results Reference
background
PubMed Identifier
23481680
Citation
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.
Results Reference
background
PubMed Identifier
33729949
Citation
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.
Results Reference
background
Links:
URL
https://fescenter.org/
Description
Cleveland Functional Electrical Stimulation Center
URL
http://restorefunction.org/
Description
Institute for Functional Restoration

Learn more about this trial

Grasp-Release Assessment of a Networked Neuroprosthesis Device

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