Spinal Cord Injury study: N1 Implant vs R1 Robot
Official title An Early Feasibility Study of a Robotically Implanted Brain-Computer Interface for Neural Control of External Devices in Spinal Cord Injury, Amyotrophic Lateral Sclerosis, and Chronic Ischemic Stroke
ClinicalTrials.gov ID: NCT07929792
What this study is testing
- What it's testing
- The purpose of this study is to look at the safety and preliminary effectiveness of the N1 System, a fully implanted brain-computer interface placed in the motor cortex with the R1 Robot.
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults with a diagnosis of ALS, spinal cord injury or chronic ischemic stroke who have severe weakness in the arms and hands that limits independent...
- Stable medical, physical and psychological condition
- Ability to communicate verbally or with a communication aid
- A caregiver available when daily support is needed
You likely can't join if
- Morbid obesity (Body Mass Index \> 40)
- History of poorly controlled seizures or epilepsy
- Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
- Prior brain implant or active implanted medical device
- Psychiatric disorder or cognitive impairment
- Recent heart attack or cardiac arrest
See the full eligibility criteria
- Adults with a diagnosis of ALS, spinal cord injury or chronic ischemic stroke who have severe weakness in the arms and hands that limits independent use of a computer or phone.
- Stable medical, physical and psychological condition
- Ability to communicate verbally or with a communication aid
- A caregiver available when daily support is needed
- Morbid obesity (Body Mass Index \> 40)
- History of poorly controlled seizures or epilepsy
- Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
- Prior brain implant or active implanted medical device
- Psychiatric disorder or cognitive impairment
- Recent heart attack or cardiac arrest
- Blood thinners that cannot be paused for surgery
- Brain MRI or CT demonstrating hemorrhage, tumor, or distorted or adverse anatomy
- Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, 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, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 years 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.