Restoration of Hand Function in Cervical SCI
Launched by METROHEALTH MEDICAL CENTER · Sep 20, 2024

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Nctid: NCT06611748

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000013119", "term"=>"Spinal Cord Injuries"}], "ancestors"=>[{"id"=>"D000014947", "term"=>"Wounds and Injuries"}, {"id"=>"D000013118", "term"=>"Spinal Cord Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000020196", "term"=>"Trauma, Nervous System"}], "browseLeaves"=>[{"id"=>"M15916", "name"=>"Spinal Cord Injuries", "asFound"=>"Spinal Cord Injury", "relevance"=>"HIGH"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M15915", "name"=>"Spinal Cord Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M22023", "name"=>"Trauma, Nervous System", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"DEVICE_FEASIBILITY", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"KeyGrip is an implantable peripheral nerve stimulator that is being studied for its ability to provide coordinated activation of innervated paralyzed muscles. KeyGrip will be configured to activate nerves of the upper extremity (arm and hand) in order to facilitate movements such as hand opening and/or closing. The study will evaluate participants; grasp strength and ability to manipulate standard objects with each participant serving as their own control, comparing stimulation ON vs. OFF."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-11-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2030-11", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-20", "studyFirstSubmitDate"=>"2024-09-18", "studyFirstSubmitQcDate"=>"2024-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2028-11", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Grasp Strength", "timeFrame"=>"baseline, 3 weeks post treatment, 12 weeks post treatment, 26-week post treatment, 52 weeks post treatment", "description"=>"Lateral grasp strength is measured with and without the stimulation to identify changes in force that contribute to object acquisition and task performance\n\nGrasp strength is how we determine the device setting to allow task performance."}], "secondaryOutcomes"=>[{"measure"=>"Grasp-Release Test (GRT)", "timeFrame"=>"baseline, 3-weeks post treatment, 12-weeks post treatment, 26-week post treatment, 52 weeks post treatment", "description"=>"The GRT is a standardized pick-and-place test that evaluates two prehensile patterns (palmar and lateral grasp) using standardized objects of different weights and sizes that are designed to mimic objects encountered in daily life.\n\nPalmer Lateral grasp strength is measured with and without the stimulation to identify changes in force that contribute to object acquisition and task performance."}, {"measure"=>"Activities of Daily Living Abilities Test", "timeFrame"=>"baseline, 12-weeks post treatment, 26-weeks post treatment, and 52-weeks post treatment", "description"=>"Functional goals will be identified by the participant. Participants will be evaluated in their level of independence in performing the tasks both with and without stimulation. Participants will rate the task on a scale of +(better), 0(same), - worse after they complete each task with the device on verse with the device off.\n\nThis test allows us to measure the impact of the device on the participants individual functional goals."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isUnapprovedDevice"=>true, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["Cervical Spinal Cord Injury (SCI)"], "conditions"=>["Spinal Cord Injury Cervical"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"http://restorefunction.org/", "label"=>"Description: Institute for Functional Restoration"}, {"url"=>"https://www.keygrip.co/", "label"=>"KeyGrip website"}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate a new method of restoring hand function to people with spinal cord injury. Current methods to restore hand function include tendon transfers and nerve transfers. This study will evaluate the grasp strength that can be achieved with a small, implantable stimulator.\n\nKeyGrip is an investigational device that works by activating paralyzed muscles with low levels of electrical current. The word \"investigational\" means the study device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA) for the use being studied.\n\nHypothesis. The study is designed to explore the feasibility of this approach; no hypothesis is planned at this stage", "detailedDescription"=>"The purpose of this study is to evaluate an alternative method of restoring hand function to people with spinal cord injury. Current methods to restore hand function include tendon transfers (surgery that moves working muscles and tendon to replace a nonworking muscle and tendon) and nerve transfers (surgery that reroutes a healthy nerve to connect to a damaged nerve and restore function or sensation). This study will evaluate the grasp strength and ability to manipulate objects that can be achieved with a small (2 inches long) implantable stimulator. The device we are using to achieve this is the Nalu Medical Peripheral Nerve Stimulator.\n\nNalu Medical Peripheral Nerve Stimulator is a stimulator currently used to treat chronic pain. The Nalu Medical Peripheral Nerve Stimulator is currently cleared for marketing by the U.S. Food and Drug Administration (FDA) for the use of spinal cord stimulation and peripheral nerve stimulation to block pain signals. The Nalu Medical Peripheral Nerve Stimulator has not been approved by the FDA for the use being tested in this study. We intend to use this device to activate paralyzed muscles. When being used for the purpose of this study, we will refer to the device as the KeyGrip System.\n\nThe KeyGrip System is an investigational use of an FDA approved device (The Nalu Medical Peripheral Nerve Stimulator) that works by activating paralyzed muscles with low levels of electrical current. The word \"investigational\" means the way we are using the device is still being tested in research studies and is not approved by the (FDA) for the use being studied. This study will use the KeyGrip System to try to restore hand function to people with spinal cord injury.\n\nWhat is involved in this study?\n\nIf the participant chooses to be in this study, the participant will undergo the following procedures:\n\n* a screening procedure that involves using surface electrical stimulation (that is, stimulation using pads placed on the skin) to evaluate whether the participants muscles can be activated with electrical stimulation.\n* Following this, the participant will undergo an evaluation of their current hand grasp strength, and the ability to perform a test of hand grasp that involves manipulating standard objects.\n* If the participants are a candidate for the study, participants will undergo surgery to implant the KeyGrip system, after which the hand and forearm will be immobilized in a cast for 3 weeks to protect the electrodes from movement.\n* Participants will then have the implant programmed to provide grasp and will be trained in how to use the system to perform activities.\n* Participants will then be able to use the system at home for exercise and for functional activities.\n* Over the course of the first year, participants will return at 3-, 6-, and 12-months to evaluate grasp strength, and ability to manipulate standard objects.\n* It is important to note that investigators do not plan to remove the study device after participation in the study ends. If participants wish to remove the study device after finishing participating or if participants withdraw from the study, a surgery to remove the device can be scheduled.\n\nParticipants will be in this research study for one year, after which participants may continue to use the device. Participants will continue to be contacted by the research team to monitor any adverse events participants may experience."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Male or female adults 18 years of age or older;\n* Cervical spinal cord injury as defined by: a) International Standard for Neurological Classification of Spinal Cord Injury motor level of C1 through C7; and b) American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C;\n* Six months or more post-injury (neurostability);\n* Neurologically stable following any nerve transfers affecting the upper extremity (typically, one-year post-surgery);\n* Musculoskeletally and neurologically stable following any tendon transfers affecting the upper extremity (typically 6 months post-surgery).\n* Peripheral nerve innervation to upper extremity muscles, including Grade 3/5 or higher Stimulated Manual Muscle Testin at least two of the muscles in one arm:\n* Good proximal voluntary upper extremity strength as defined by biceps/ brachialis / brachioradialis strength of 2/5 or higher on Manual Muscle Testing the side intended for implantation;\n* Medically stable; and\n* Able to understand and provide informed consent;\n\nExclusion Criteria:\n\n* Other neurological conditions (Multiple Sclerosis, diabetes with peripheral nerve involvement);\n* Associated peripheral nerve / brachial plexus injury;\n* Progressive Spinal Cord Injury;\n* Active implantable medical device (AIMD) such as a pacemaker or defibrillator;\n* Active untreated infection such as urinary tract infection or pneumonia;\n* Active pressure injury;\n* 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;\n* Unhealed fractures that prevent functional use of arm;\n* Extensive upper extremity denervation (fewer than two excitable hand muscles);\n* Involvement in other ongoing clinical studies that exclude concurrent involvement in this study;\n* Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant based on self-report); Urine or serum testing will happen during the pre-surgery evaluation.\n* Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;\n* Other significant medical findings that, in the opinion of the investigator, preclude safe participation in the trial"}, "identificationModule"=>{"nctId"=>"NCT06611748", "acronym"=>"KeyGrip", "briefTitle"=>"Restoration of Hand Function in Cervical SCI", "organization"=>{"class"=>"OTHER", "fullName"=>"MetroHealth Medical Center"}, "officialTitle"=>"Evaluation of a Simple Neuroprosthesis for Restoration of Hand Function in Cervical Spinal Cord Injury", "orgStudyIdInfo"=>{"id"=>"STUDY00000625"}, "secondaryIdInfos"=>[{"id"=>"ID573-FY24-25", "type"=>"OTHER_GRANT", "domain"=>"Ohio Department of Education"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"KeyGrip device implantation", "description"=>"The KeyGrip system components will be implanted in a single surgical procedure, lasting up to 90 minutes.\n\nFor this study, a small receiver will be placed under the skin in the forearm. Two to four stimulating electrodes will be surgically placed in muscles of the hand or arm. Wires from these electrodes will be tunneled beneath the skin and connected to the receiver device located in the forearm.\n\nThe study participant will control the electrical stimulation by using a phone app that communicates to a power unit that is placed on the skin over the receiver. Following implantation of the device, periodic evaluations will be performed to assess their condition, and the operation and usefulness of the device.\n\nDepending on the study participant's usage level, they may need to recharge the batteries every night.", "interventionNames"=>["Device: Key Grip"]}], "interventions"=>[{"name"=>"Key Grip", "type"=>"DEVICE", "description"=>"KeyGrip is an implantable peripheral nerve stimulator that is being studied for its ability to provide coordinated activation of innervated paralyzed muscles. KeyGrip will be configured to activate nerves of the upper extremity (arm and hand) in order to facilitate movements such as hand opening and/or closing", "armGroupLabels"=>["KeyGrip device implantation"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Kim Walsh, OTR/L", "role"=>"CONTACT", "email"=>"kwalsh3@metrohealth.org", "phone"=>"216-957-3512"}, {"name"=>"Krissy Hansen, PT", "role"=>"CONTACT", "email"=>"khansen1@metrohealth.org", "phone"=>"2169573584"}], "overallOfficials"=>[{"name"=>"Megan Moynahan", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"MetroHealth Medical Center"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"MetroHealth Medical Center", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Megan Moynahan", "investigatorAffiliation"=>"MetroHealth Medical Center"}}}}

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Trial Information

Current as of October 08, 2024

Not yet recruiting

Keywords

Cervical Spinal Cord Injury (Sci)

Description

The purpose of this study is to evaluate an alternative method of restoring hand function to people with spinal cord injury. Current methods to restore hand function include tendon transfers (surgery that moves working muscles and tendon to replace a nonworking muscle and tendon) and nerve transfers (surgery that reroutes a healthy nerve to connect to a damaged nerve and restore function or sensation). This study will evaluate the grasp strength and ability to manipulate objects that can be achieved with a small (2 inches long) implantable stimulator. The device we are using to achieve this...

Gender

ALL

Eligibility criteria

Inclusion Criteria:
* Male or female adults 18 years of age or older;
* Cervical spinal cord injury as defined by: a) International Standard for Neurological Classification of Spinal Cord Injury motor level of C1 through C7; and b) American Spinal Injury Association 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 post-surgery).
* Peripheral nerve innervation to upper extremity muscles, including Grade 3/5 or higher Stimulated Manual Muscle Testin at least two of the muscles in one arm:
* Good proximal voluntary upper extremity strength as defined by biceps/ brachialis / brachioradialis strength of 2/5 or higher on Manual Muscle Testing the side intended for implantation;
* Medically stable; and
* Able to understand and provide informed consent;
Exclusion Criteria:
* Other neurological conditions (Multiple Sclerosis, diabetes with peripheral nerve involvement);
* Associated peripheral nerve / brachial plexus injury;
* Progressive Spinal Cord Injury;
* Active implantable medical device (AIMD) such as a pacemaker or defibrillator;
* Active untreated infection such as urinary tract infection or pneumonia;
* Active pressure injury;
* 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;
* Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant based on self-report); Urine or serum testing will happen during the pre-surgery evaluation.
* 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

About Metrohealth Medical Center

MetroHealth Medical Center is a leading healthcare institution dedicated to advancing medical research and improving patient care through innovative clinical trials. As a prominent sponsor, MetroHealth collaborates with multidisciplinary teams to explore cutting-edge treatments and therapies across various medical fields. With a commitment to ethical research practices and participant safety, the center leverages its extensive resources and expertise to contribute to the scientific community and enhance healthcare outcomes. Through rigorous clinical trials, MetroHealth aims to translate research findings into tangible benefits for patients, fostering a culture of excellence in clinical research.

Locations

People applied

0 patients applied

Timeline

First submit

September 18, 2024

Trial launched

November 01, 2024

Trial updated

September 20, 2024

Estimated completion

Not reported

Discussion 0

Restoration of Hand Function in Cervical SCI Launched by METROHEALTH MEDICAL CENTER · Sep 20, 2024

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Restoration of Hand Function in Cervical SCI
Launched by METROHEALTH MEDICAL CENTER · Sep 20, 2024