NCT07224256Recruiting
VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
Source: ClinicalTrials.gov · Last updated 4 Nov 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 13 Oct 2025
- Start date
- Oct 2025
- Primary completion date
- Oct 2028
- Lead sponsor
- Neuralink Corp
- Diseases
- ALS (motor neurone disease), Stroke
- NCT number
- NCT07224256
What you commit to
- Study type: Interventional
- Planned participants: 6
- From Oct 2025 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of poorly controlled seizures or epilepsy
- History of poorly controlled diabetes
- Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
- 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
Other
- Moderate to high risk for serious perioperative adverse events
- Morbid obesity (Body Mass Index \> 40)
- Acquired or hereditary immunosuppression
Who the study is looking for
- 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
Age in the registry: 22 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.