Tetraplegia/TetraparesisGB-PRIMENCT07127172
GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
A study testing N1 Implant and R1 Robot in people with Tetraplegia/Tetraparesis and Quadriplegia, run by Neuralink Corp at 2 sites in United Kingdom.
Trial summary
The GB-PRIME Study is an early feasibility study designed to assess the clinical safety and functionality of the Neuralink N1 Implant and R1 Robot. This study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia
- What is being tested?
- N1 Implant and R1 Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 31 Jul 2025to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (a) A diagnosis of a spinal cord injury, brain stem stroke, or other neurological condition causing the participant to be non-ambulant and with bilateral upper limb motor impairment with no expectation of recovery that significantly or completely impairs the participant's ability to manually control a computer, smartphone or tablet with their hands.
- OR (b) A diagnosis of Amyotrophic Lateral Sclerosis (ALS) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation in the view of the participants treating neurologist that the disease will progress such that the participant will meet 1a within 1 year of recruitment.
- Life expectancy ≥ 12 months.
- Ability to communicate in English
- Presence of a stable caregiver
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
University College London Hospitals NHS Foundation Trust
London, Greater London, WC1N 3BG
Mr. Harith Akram, MBChB, PhD, FRCS (Neuro.Surg)
- Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, NE2 4HH
Mr. Mohammed Hussain, MD
About this study
The GB-PRIME Study is an early feasibility study designed to assess the clinical safety and functionality of the Neuralink N1 Implant and R1 Robot. This study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions.
The N1 Implant is a wireless, rechargeable device mounted on the skull, connected to electrode threads that are inserted into the brain by the R1 Robot, which is a robotic device specifically designed for this procedure.
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Injury (Quadraplegia)
- Being tested
- N1 Implant, R1 Robot
- Keywords
- brain computer interface, Neuralink N1 Implant, Neuralink, Robot, tetraparesis, tetraplegia, quadriplegia, ALS, spinal cord injury, Amyotrophic lateral sclerosis, chip, brain chip, External device control, Wireless implant, Neuroprosthetics, SCI, paralysis, motor neuron disease
- Medical subject headings
- Quadriplegia, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries, Motor Neuron Disease, Brain Stem Infarctions, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1 ImplantDevice
The N1 Implant is a type of implantable brain-computer interface.
R1 RobotDevice
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
| Study group | Role | What they receive |
|---|---|---|
| GB-PRIME: Precise Robotically Implanted Brain-Computer Interface | Other | Open label Receives: Device: N1 Implant; Device: R1 Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Device-Related Adverse Events (AE)
Measured: 12 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Measured: 12 months post-implant
Secondary outcomes (8)
The Rate of Device-Related Adverse Events (AE)
Measured: Up to 48 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Measured: Up to 48 months post-implant
Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study
The Montreal Cognitive Assessment (MoCA) is a 30-point scale assessing cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Outcome will be reported as change from baseline at each follow-up visit.
Measured: From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase
The Montreal Cognitive Assessment (MoCA) is a 30-point scale assessing cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Outcome will be reported as change from baseline at each follow-up visit.
Measured: From baseline to 48-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale used to assess depression severity. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Outcome will be reported as change from baseline at each follow-up visit.
Measured: From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale used to assess depression severity. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Outcome will be reported as change from baseline at each follow-up visit.
Measured: From baseline to 48-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study
The Generalized Anxiety Disorder 7-item (GAD-7) scale assesses anxiety severity. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Outcome will be reported as change from baseline at each follow-up visit.
Measured: From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase
The Generalized Anxiety Disorder 7-item (GAD-7) scale assesses anxiety severity. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Outcome will be reported as change from baseline at each follow-up visit.
Measured: From baseline to 48-months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start31 Jul 2025
- Primary completionJan 2028 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetraplegia/TetraparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a pre UKCA/CE, prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS)
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuralink Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, University College London Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127172
- Sponsor's protocol ID
- N1-EFS-006
- Other IDs
- 354112
- Acronym
- GB-PRIME
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
- ClinicalTrials.gov ID
- NCT07127172
- Acronym / sponsor ID
- GB-PRIME / N1-EFS-006
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Injury (Quadraplegia)
- Keywords
- brain computer interface, Neuralink N1 Implant, Neuralink, Robot, tetraparesis, tetraplegia, quadriplegia, ALS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Neuralink CorpIndustry (pharma, biotech, devices)
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, University College London Hospitals
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The GB-PRIME Study is an early feasibility study designed to assess the clinical safety and functionality of the Neuralink N1 Implant and R1 Robot. This study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions.
The N1 Implant is a wireless, rechargeable device mounted on the skull, connected to electrode threads that are inserted into the brain by the R1 Robot, which is a robotic device specifically designed for this procedure.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a pre UKCA/CE, prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS)
| Arm | Type | Receives |
|---|---|---|
| GB-PRIME: Precise Robotically Implanted Brain-Computer Interface | Other | Device: N1 Implant, Device: R1 RobotOpen label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (a) A diagnosis of a spinal cord injury, brain stem stroke, or other neurological condition causing the participant to be non-ambulant and with bilateral upper limb motor impairment with no expectation of recovery that significantly or completely impairs the participant's ability to manually control a computer, smartphone or tablet with their hands.
- OR (b) A diagnosis of Amyotrophic Lateral Sclerosis (ALS) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation in the view of the participants treating neurologist that the disease will progress such that the participant will meet 1a within 1 year of recruitment.
- Life expectancy ≥ 12 months.
- Ability to communicate in English
- Presence of a stable caregiver
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N1 ImplantThe N1 Implant is a type of implantable brain-computer interface. | Device | GB-PRIME: Precise Robotically Implanted Brain-Computer Interface |
| R1 RobotThe R1 Robot is a robotic electrode thread inserter that implants the N1 Implant. | Device | GB-PRIME: Precise Robotically Implanted Brain-Computer Interface |
Primary outcome
The Rate of Device-Related Adverse Events (AE)
Time frame: 12 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time frame: 12 months post-implant
8 secondary outcomes
The Rate of Device-Related Adverse Events (AE)
Time frame: Up to 48 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time frame: Up to 48 months post-implant
Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study
Time frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation
Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase
Time frame: From baseline to 48-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study
Time frame: From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation
Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase
Time frame: From baseline to 48-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study
Time frame: From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation
Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase
Time frame: From baseline to 48-months post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Neuralink UK Patient RegistryLink provided by the sponsor.
- Neuralink WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N1 Implant and R1 Robot in people with Tetraplegia/Tetraparesis and Quadriplegia, run by Neuralink Corp at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neuralink Clinical Team ((877) 398-4465, clinical-team-ct@neuralink.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Rate of Device-Related Adverse Events (AE) (time frame: 12 months post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.