Tetraplegia/TetraparesisNCT07224256
VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
A study testing N1 Implant and R1 Robot in people with Tetraplegia/Tetraparesis and Quadriplegia, run by Neuralink Corp at 1 site in United States.
Trial summary
The VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury
- 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
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2025to Oct 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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with diagnosis of ALS, PLS, stroke, or Spinal Cord Injury who have severe speech impairment and impaired upper limb function.
- 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
- 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
Show all 9Show fewer
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Nader Pouratian, MD, 214-645-1355, voice-study@neuralink.com
Nader Pouratian, MD
About this study
The VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate. The Neuralink N1 Implant is intended to provide the ability to communicate to individuals with severe and irreversible speech production impairment. It is indicated for adults with neurological conditions of the central speech pathways who have impaired upper limb function. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Quadriplegia/Tetraplegia, Tetraplegic; Paralysis
- Being tested
- N1 Implant, R1 Robot
- Keywords
- stroke, spinal cord injury, SCI, ALS, brain computer interface, BCI, PLS, voice, speech, dysarthria, neuralink
- Medical subject headings
- Quadriplegia, Amyotrophic Lateral Sclerosis, Paralysis, Stroke, Spinal Cord Injuries, Speech, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1 ImplantDevice
Also called Neuralink N1 Implant, N1, Telepathy, Link
The N1 Implant is a type of implantable brain-computer interface
R1 RobotDevice
Also called R1, Neuralink R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
| Study group | Role | What they receive |
|---|---|---|
| Neuralink N1 Implant and R1 Robot | Experimental | Implantation of the N1 Implant by the R1 Robot. Receives: Device: N1 Implant; Device: R1 Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-Related Adverse Events (AE)
The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit.
Measured: 12 months post-implant
Procedure-Related Adverse Events (AE)
The proportion of subjects with procedure-related adverse events (AEs) at the 12-month follow-up visit.
Measured: 12 months post-implant
Secondary outcomes (4)
Long-term Device-Related Adverse Events (AE)
The proportion of subjects with device-related adverse events (AEs) up to the 48-month long-term follow-up visit.
Measured: Up to 48 months post-implant
Long-term Procedure-Related Adverse Events (AE)
The proportion of subjects with procedure-related adverse events (AEs) up to the 48-month follow-up visit.
Measured: Up to 48 months post-implant
Preliminary efficacy of the R1 Robot
Preliminary efficacy of the R1 Robot will be evaluated by measuring the following percent of electrodes inserted (reported as electrodes inserted / total electrodes).
Measured: During surgical implantation procedure
Preliminary efficacy of the N1 Implant
Preliminary efficacy of the N1 Implant will be evaluated by measuring the following BCI performance for speech, quantified by measuring the monthly maximum correct word per minute (CWPM).
Measured: Up to 48 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start3 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuralink Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nader Pouratian, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224256
- Sponsor's protocol ID
- N1-EFS-200
- Status last verified
- Oct 2025
- First submitted
- 13 Oct 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
- ClinicalTrials.gov ID
- NCT07224256
- Acronym / sponsor ID
- N1-EFS-200
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Quadriplegia/Tetraplegia, Tetraplegic; Paralysis
- Keywords
- stroke, spinal cord injury, SCI, ALS, brain computer interface, BCI, PLS, voice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Neuralink CorpIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 4 Nov 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 VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate. The Neuralink N1 Implant is intended to provide the ability to communicate to individuals with severe and irreversible speech production impairment. It is indicated for adults with neurological conditions of the central speech pathways who have impaired upper limb function. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuralink N1 Implant and R1 Robot | Experimental | Device: N1 Implant, Device: R1 RobotImplantation of the N1 Implant by the R1 Robot. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults with diagnosis of ALS, PLS, stroke, or Spinal Cord Injury who have severe speech impairment and impaired upper limb function.
- Life expectancy ≥ 12 months.
- Ability to communicate in English
- Presence of a stable caregiver
Key exclusion criteria (9 listed)
- Moderate to high risk for serious perioperative adverse events
- 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
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 ImplantAlso: Neuralink N1 Implant, N1, Telepathy, LinkThe N1 Implant is a type of implantable brain-computer interface | Device | Neuralink N1 Implant and R1 Robot |
| R1 RobotAlso: R1, Neuralink R1 RobotThe R1 Robot is a robotic electrode thread inserter that implants the N1 Implant. | Device | Neuralink N1 Implant and R1 Robot |
Primary outcome
Device-Related Adverse Events (AE)
Time frame: 12 months post-implant
The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit.
Procedure-Related Adverse Events (AE)
Time frame: 12 months post-implant
The proportion of subjects with procedure-related adverse events (AEs) at the 12-month follow-up visit.
4 secondary outcomes
Long-term Device-Related Adverse Events (AE)
Time frame: Up to 48 months post-implant
Long-term Procedure-Related Adverse Events (AE)
Time frame: Up to 48 months post-implant
Preliminary efficacy of the R1 Robot
Time frame: During surgical implantation procedure
Preliminary efficacy of the N1 Implant
Time frame: Up to 48 months post-implant
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 4 Nov 2025.
- https://neuralink.com/Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nader Pouratian, MD principal investigator
University of Texas Southwestern Medical Center
1 site 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 1 site in United States.
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 4 inclusion and 9 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 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 (+1 (650) 250-0520, voice-study@neuralink.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 4 Nov 2025.