Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611748
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Restoration of Hand Function in Cervical SCI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of a Simple Neuroprosthesis for Restoration of Hand Function in Cervical Spinal Cord Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KeyGrip
Brief Summary:
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
KeyGrip 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 US Food and Drug Administration FDA for the use being studied
Hypothesis The study is designed to explore the feasibility of this approach no hypothesis is planned at this stage
KeyGrip 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 US Food and Drug Administration FDA for the use being studied
Hypothesis The study is designed to explore the feasibility of this approach no hypothesis is planned at this stage
Detailed 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 is the Nalu Medical Peripheral Nerve Stimulator
Nalu 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 US 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
The 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
What is involved in this study
If the participant chooses to be in this study the participant will undergo the following procedures
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
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
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
Participants will then have the implant programmed to provide grasp and will be trained in how to use the system to perform activities
Participants will then be able to use the system at home for exercise and for functional activities
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
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
Participants 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
Nalu 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 US 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
The 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
What is involved in this study
If the participant chooses to be in this study the participant will undergo the following procedures
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
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
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
Participants will then have the implant programmed to provide grasp and will be trained in how to use the system to perform activities
Participants will then be able to use the system at home for exercise and for functional activities
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
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
Participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None