Spinal Cord Injury (Quadraplegia)
Conditions
Brief summary
The purpose of this clinical study is to allow the investigation of the Neural Bridging System for participants with tetraplegia to assess if the investigational device can reanimate a paralyzed limb under voluntary control by the participant's thoughts.
Detailed description
This study plans to enroll participants who have been diagnosed with C4- C6 ASIA A spinal cord injuries (motor and sensory complete neurologic injuries), who are more than 1 year post injury, and who are neurologically stable.
Interventions
DEVICENeural Bridge System
Implanted device
Sponsors
Marcia Bockbrader
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Must be 21 years or older. * Must be tetraplegic (C4- C6 ASIA A). * 12 months post injury and neurologically stable. * Participant is willing to comply with all follow-up evaluations at the specified times. * Participant is able to provide informed consent prior to enrollment in the study. * The participant is fluent in English. * Participant must have a caregiver willing to participate in the study who will provide care for the surgical site.
Exclusion criteria
* No active wound healing or skin breakdown issues. * No history of poorly controlled autonomic dysreflexia. * Medical contraindications for general anesthesia, craniotomy, or surgery. * Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months. * Participants with any type of destruction and/or damage to the motor cortex region as determined by MRI. * History of psychiatric disturbance or dementia * Other implantable devices such as heart/brain pacemakers * Participants who rely on ventilators * Co-morbid conditions that would interfere with study activities or response to treatment. * History of a neurological ablation procedure. * Labeled contraindication for MRI. * History of hemorrhagic stroke. * History of HIV infection or ongoing chronic infection (such as tuberculosis). * Pregnant or of child-bearing potential and are not taking acceptable methods of contraception. * Participation in another FDA device or medication trial that would interfere with the current study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Voluntary Movement | 9 months | The primary outcome measure of this study is the achievement of voluntary hand movement using the neural bridge system |
Countries
United States
Participant flow
Recruitment details
Recruited 2013-2015 from a tertiary care center rehabilitation clinic
Participants by arm
| Arm | Count |
|---|---|
| Neural Bridge System - Open Label Neural bridge system implant and external stimulator
Neural Bridge System: Implanted device | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Neural Bridge System - Open Label |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Number of participants with voluntary movement Evoked movement - able | 0 Participants |
| Number of participants with voluntary movement Evoked movement - unable | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 1 / 1 |
Outcome results
Primary
Number of Participants With Voluntary Movement
The primary outcome measure of this study is the achievement of voluntary hand movement using the neural bridge system
Time frame: 9 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neural Bridge System - Open Label | Number of Participants With Voluntary Movement | Voluntary Movement - able | 1 Participants |
| Neural Bridge System - Open Label | Number of Participants With Voluntary Movement | Voluntary Movement - unable | 0 Participants |