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New treatment option for Spinal Cord Injuries
Official title Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
ClinicalTrials.gov ID: NCT03680872
What this study is testing
- What it's testing
- 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.
- Time commitment: about 48 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Prior difficulties or allergy to general anesthesia
- Active wound healing or skin breakdown issues
- Stage III-IV pressure ulcers
See the full eligibility criteria
- 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...
- 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
- 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
- Cancer
- Biochemical abnormalities of the liver, kidney, or pancreas
- Ventilator dependence
- History of serious mood or thought disorder
- Significant residual clinically evident traumatic brain injury or cognitive impairment
- Uncontrolled autonomic dysreflexia
- Spasticity in the upper extremities that is uncontrolled by pharmacological methods
- Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months
- Individuals with any type of destruction and/or damage to the motor cortex region as determined by fMRI.
- History of a neurological ablation procedure
- History of hemorrhagic stroke
- History of infectious or chronic diseases, such as HIV or tuberculosis
- Individuals with any of the following co-morbid conditions that would interfere with study activities or response to treatment:
- Life expectancy \< 3 years
- Severe chronic pulmonary disease
- Intractable seizure disorders
- Local, systemic acute or chronic infectious illness
- Life threatening cardiac arrhythmias
- Severe collagen vascular disorder
- Kidney failure or other major organ systems failures
- Individuals with a substance abuse (alcoholism or other) problem
- Pregnant women
- Prisoners
The study team makes the final eligibility decision.
Where it's taking place
- Manhasset, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 48 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manhasset, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.