Evaluation of a Simple Neuroprosthesis for Restoration of Hand Function in Cervical Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Grasp-Release Test (GRT)
研究概览
简要总结
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 U.S. 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
详细描述
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 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.
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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
研究组 & 干预措施
KeyGrip device implantation
The KeyGrip system components will be implanted in a single surgical procedure, lasting up to 90 minutes.
For this study, a small receiver will be placed under the skin in the forearm. Up to four stimulating electrodes(investigational) 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.
The 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.
Depending on the study participant's usage level, they may need to recharge the batteries every night.
干预措施: Key Grip (Device)
KeyGrip device implantation
The KeyGrip system components will be implanted in a single surgical procedure, lasting up to 90 minutes.
For this study, a small receiver will be placed under the skin in the forearm. Up to four stimulating electrodes(investigational) 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.
The 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.
Depending on the study participant's usage level, they may need to recharge the batteries every night.
干预措施: Implanted Key Grip Electrodes (Device)
结局指标
主要结局
Grasp-Release Test (GRT)
时间窗: baseline, 3-weeks post treatment, 12-weeks post treatment, 26-week post treatment, 52 weeks post treatment
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.
次要结局
- Grasp Strength(baseline, 3 weeks post treatment, 12 weeks post treatment, 26-week post treatment, 52 weeks post treatment)
- Activities of Daily Living Abilities Test(baseline, 12-weeks post treatment, 26-weeks post treatment, and 52-weeks post treatment)
- Canadian Occupational Performance Measure (COPM)(baseline, 12-weeks post treatment, 26-weeks post treatment, and 52-weeks post treatment)
研究者
Megan Moynahan
Principal Investigator
MetroHealth Medical Center