Ignite Creation Date:
2024-05-06 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03680872
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2018-08-27
Brief Title:
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
Sponsor:
Chad Bouton
Organization:
Northwell Health
Study Overview
Official Title:
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 three individuals with tetraplegia
Detailed Description:
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 Researchs Center for Bioelectronic Medicine Participants will attend up to 3 study sessions a week for approximately 12 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 andor 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 3 participants completion of study procedures by all participants and the completion of analysis of identifiable study data
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 Researchs Center for Bioelectronic Medicine Participants will attend up to 3 study sessions a week for approximately 12 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 andor 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 3 participants completion of study procedures by all participants and the completion of analysis of identifiable study data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None