Neuralink's first clinical trial is open to recruitment.
You are invited to participate in the current Neuralink's PRIME Study or the future Neuralink clinical trials. Neuralink PRIME Study is a groundbreaking investigational medical device clinical trial for Neuralink's first brain-computer interface (BCI)
Neuralink is seeking the opportunity to meet you for the Neuralink PRIME Study or the future Neuralink clinical trials.
The PRIME Study – a groundbreaking investigational medical device trial for our fully-implantable, wireless brain-computer interface (BCI) – aims to evaluate the safety of our implant and surgical robot, and assess the initial functionality of our BCI for enabling people with quadriplegia to control external devices with their thoughts.
This study involves placing a small, cosmetically invisible implant in a part of the brain that plans movements. The device is designed to interpret a person’s neural activity, so they can operate a computer or smartphone by simply intending to move – no wires or physical movement are required.
This research will be the first of its kind to be performed in people and may help us find safer, more effective ways to implant and use our BCI to potentially restore and enhance computer control and other capabilities.
If you have limited or no ability to use both hands due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) you may qualify.
Download the Neuralink PRIME Study brochure below.
Why did Neuralink create a Patient Registry?
We are committed to developing devices to restore autonomy to those with unmet medical needs with input from the communities and individuals we aim to serve. The Patient Registry allows us to connect with and understand the needs of a diverse group of individuals with various conditions. The Patient Registry also helps us determine your preliminary eligibility for current and/or future Neuralink clinical trials.
Who can participate in the Patient Registry?
Anyone within the United States who is at least 18 years old and the age of majority in their state, who is able to consent, and who has quadriplegia, paraplegia, vision loss, hearing loss, the inability to speak, and/or major limb amputation (affecting above or below the elbow and/or above or below the knee), is invited to participate in the Patient Registry.
What benefit do I gain from adding my information to the Neuralink Patient Registry?
While there is no direct benefit from participating in the Patient Registry, you may benefit in the future from research stemming from the Patient Registry and any commercial products that may result. If you submit a completed Patient Registry application, we may also contact you or your legally authorized representative about your eligibility for current and/or future Neuralink clinical trials.
What information is collected through the Patient Registry?
We will ask about current and past medical information, demographics, education, work, and the assistive technologies you use. To participate in the Patient Registry, we will ask you for your authorization to release your medical records. If you have a legally authorized representative, we will ask for their contact information.
How will my information be used and by whom?
We will not sell the data you provide to any third party. We may share such data with Neuralink’s affiliates, third parties acting on behalf of Neuralink and research partners. The information you provide may be used to determine your potential eligibility for current and/or future Neuralink clinical trials as well as for research purposes and potential product development. Your contact information may also be used to communicate with you (or your legally authorized representative) about your Patient Registry application, Neuralink, Neuralink clinical trials, or Neuralink’s technology. If required, we may also share information you provide with regulatory agencies, such as an institutional review board (IRB), to comply with Neuralink’s regulatory obligations or to comply with the law. Only authorized Neuralink personnel with the appropriate privacy and confidentiality training and authorized third parties will be able to access the identifiable personal information you provide. We may create de-identified data from the identifiable personal information you provide by excluding information that personally identifies you. This de-identified data may be presented at scientific, professional, or company meetings, or published in scientific journals.
Does adding my information to the Patient Registry help me qualify for current and/or future clinical trials?
We may use the information you provide to determine your preliminary eligibility for current and/or future Neuralink clinical trials. Participation in the Patient Registry is however not a prerequisite or sufficient for later participation in a Neuralink clinical trial. You will not be considered enrolled into any Neuralink clinical trials and/or research study by participating in the Patient Registry. You will be asked to review and sign a separate informed consent document before participating in any current and/or future Neuralink clinical trial. Neuralink currently has one clinical trial available for enrollment.
Can you tell me about current and/or upcoming clinical trials?
Neuralink has one clinical trial available for enrollment. If you participate in the Patient Registry and we determine that you meet preliminary eligibility for current and/or future clinical trials, we may contact you to inform you of these trials.
We've received approval from the reviewing independent ethics board and our first hospital site to begin recruitment for our first-in-human clinical trial!
The PRIME Study – a groundbreaking investigational medical device trial for our fully-implantable, wireless brain-computer interface (BCI) – aims to evaluate the safety of our implant and surgical robot, and assess the initial functionality of our BCI for enabling people with quadriplegia to control external devices with their thoughts.
This study involves placing a small, cosmetically invisible implant in a part of the brain that plans movements. The device is designed to interpret a person’s neural activity, so they can operate a computer or smartphone by simply intending to move – no wires or physical movement are required.
This research will be the first of its kind to be performed in people and may help us find safer, more effective ways to implant and use our BCI to potentially restore and enhance computer control and other capabilities.
If you have limited or no ability to use both hands due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) you may qualify.
To learn more:
download the study brochure here
If you're interested in learning whether you may qualify for current and/or future Neuralink clinical trials, consider joining our Patient Registry.
How do I withdraw my application from the Patient Registry?
Upon providing your consent to participate in the Patient Registry, you have the right to withdraw your consent at any time by contacting us at
patientregistry@neuralink.com.
Upon receiving your withdrawal request, Neuralink will stop any use and further collection of your data (e.g., obtaining authorized medical records) as soon as reasonably possible, and will delete your records from the Patient Registry within 90 business days of receipt of such request. Upon receipt of your withdrawal request, Neuralink will also request that third parties with whom it shared Patient Registry data stop using the data and delete such data in a reasonable timeframe. While your withdrawal will be effective upon receipt by Neuralink, it will not be effective to the extent that Neuralink or others have already relied upon this consent, which means that any processing of your data prior to the receipt of your withdrawal request cannot be undone.
Apply for Consideration
If you're interested in helping us develop general-purpose brain-computer interfaces with the potential to help restore independence to individuals with disabilities, consider joining the Patient Registry. If you have any questions or concerns, feel free to reach out to patientregistry@neuralink.com.