Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
概览
- 阶段
- 不适用
- 干预措施
- Bidirectional Neural Bypass System
- 疾病 / 适应症
- Spinal Cord Injuries
- 发起方
- Chad Bouton
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Restoration of Movement
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
This is a single-cohort early feasibility trial to determine whether an investigational device called the Bidirectional Neural Bypass System can lead to the restoration of movement and sensation in the hand and wrist of up to seven individuals with tetraplegia.
详细描述
This study consists of the following three phases: baseline visit, surgical procedure, and restoration sessions. At the baseline visit, participants will undergo a medical history review, physical and neurological examination, functional assessment of motor and sensory capabilities, a functional magnetic resonance image (fMRI), diffusion tensor image (DTI), and a transcutaneous neuromuscular and transcutaneous spinal cord stimulation test. Participants deemed eligible for continued participation will then undergo a craniotomy under anesthetic sedation to implant the investigational device. The surgeon will implant microelectrode arrays into the primary motor cortex to record neural activity associated with desired movements and into the primary somatosensory cortex to deliver stimulation in order to provide sensory perception. While in surgical recovery, participants will have their vital signs monitored, be provided pain medication and antibiotics, and undergo a computed tomography (CT). The participants may also undergo electromyography and microneurography while in recovery. After being evaluated by a physician, the participants will be discharged from the hospital to continue their recovery. After fully recovering, participants will attend restoration sessions at the Feinstein Institute for Medical Research's Center for Bioelectronic Medicine. Participants will attend up to 3 study sessions a week for approximately 48 months, with each session lasting up to 4 hours. The sessions will progressively focus on identifying neural activity related to desired movements, restoring volitional control of the hand and wrist, restoring tactile perception, and then restoring volitional control and tactile perception of the hand and wrist simultaneously. During the sessions, participants will have brain signals recorded from electrodes implanted in the brain, receive transcutaneous electrical stimulation to the arm and/or spinal cord, and receive a small amount of electrical current to the electrodes implanted in the brain. The participants may also undergo electromyography and microneurography during some of the sessions. The study will be considered complete after completion of enrollment (up to 7 participants), completion of study procedures by all participants, and the completion of analysis of identifiable study data.
研究者
Chad Bouton
Vice President, Advanced Engineering; Managing Director, Center for Bioelectronic Medicine
Northwell Health
入排标准
入选标准
- •Males and females between 22 and 65 years of age
- •Individuals with a stable cervical spinal cord injury that have International Standards for the Neurological Classification of SCI (ISNCSCI) motor scores for fingers of 0 - 2 (non-functional) and ISNCSCI sensory scores of 0 - 2 (not normal) on the palmar side
- •Individuals at least one year from initial spinal cord injury
- •Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions
- •Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation.
- •Individuals that are willing and able to visit the study center for study procedures that will be 1-3 sessions a week for up to 48 months at 1-4 hours per session.
- •Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies
- •Demonstrate typical amplitude, latency, and conduction velocity in the distal median, ulnar, and radial nerves of at least one upper limb
排除标准
- •Individuals participating in another research study that may affect the conduct or results of this study
- •Individuals having or exhibiting any of the following:
- •Medical contraindications for diffusion tensor imaging, functional magnetic resonance imaging, electromyography, computed tomography, cortical stimulation, or craniotomies/surgeries
- •Prior difficulties or allergy to general anesthesia
- •Active wound healing or skin breakdown issues
- •Stage III-IV pressure ulcers
- •Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)
- •Prior tendon transfer to enhance hand function
- •History of autoimmune disease
- •Biochemical abnormalities of the liver, kidney, or pancreas
研究组 & 干预措施
Spinal Cord Injury Participants
This group consists of individuals with tetraplegia receiving an investigational device called the Bidirectional Neural Bypass System.
干预措施: Bidirectional Neural Bypass System
结局指标
主要结局
Restoration of Movement
时间窗: The primary outcome will be assessed over the course of 48 months during the study's restoration sessions.
The primary outcome of restoring movement will be evaluated through Graded Redefined Assessment of Strength, Sensibility \& Prehension. The performance will be graded on a numeric scale from 0-92, where a higher number indicates a better outcome. Participants will complete 10 distinct arm, wrist, and finger movements. The movements will be evaluated on a 5-point scale ranging from no movement to normal movement for a total of 0-50. Participants will be asked to perform a cylindrical grasp, key pinch, and a thumb-index pinch. The movements will be evaluated on a 4-point scale ranging from an inability to position wrist and fingers to able to perform movement with normal force for a total of 0-12. Participants will be asked to pour water, unscrew lids, place pegs on a board, open a lock, drop coins in a slot, and screw nuts. The movements will be evaluated on a 5-point scale ranging from 0% completed to 100% completed with expected grasp and no difficulties for a total of 0-30.
Restoration of Sensation
时间窗: The primary outcome will be assessed over the course of 48 months during the study's restoration sessions.
The primary outcome of restoring the perception of tactile sensation of the hand will be evaluated through the 5-Point Likert Scale. Participants will be asked whether they perceive sensation in response to objects being placed against the hand and fingertips. Participants will indicate whether they feel the object by selecting either strongly disagree (1), disagree (2), neutral (3), agree (4), or strongly agree (5). A higher total response score indicates an improvement in outcome.