Tetraplegia/Tetraparesis study: N1 Implant vs R1 Robot
Official title CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
ClinicalTrials.gov ID: NCT06700304
What this study is testing
- What it's testing
- This study checks if a new brain device and a robot used to place it are safe and work as intended.
- Who it's for
- The study is looking for people with conditions that cause weakness or paralysis in all four limbs.
- What's involved
- Participants will have a small wireless device implanted in their skull. A robot will help place tiny threads into the brain to connect the device.
- Time commitment
- The source text does not specify the total duration or number of visits required.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where...
- Life expectancy ≥ 12 months.
- Ability to communicate in English
- Presence of a stable caregiver
You likely can't join if
- Moderate to high risk for serious perioperative adverse events
- Active implanted devices
- Morbid obesity (Body Mass Index \> 40)
- History of poorly controlled seizures or epilepsy
- History of poorly controlled diabetes
- Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
See the full eligibility criteria
- Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm...
- Life expectancy ≥ 12 months.
- Ability to communicate in English
- Presence of a stable caregiver
- Moderate to high risk for serious perioperative adverse events
- Active implanted devices
- Morbid obesity (Body Mass Index \> 40)
- History of poorly controlled seizures or epilepsy
- History of poorly controlled diabetes
- Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
- Acquired or hereditary immunosuppression
- Use of smoking tobacco or other tobacco products
- Psychiatric or psychological disorder
- Brain MRI demonstrating hemorrhage, tumor, 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
- Toronto, Ontario, Canada
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. 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.