Brain-Computer Interface for Severe Speech Impairment
VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
Recruiting
N/A
Interventional Study
Tetraplegia/Tetraparesis
Quadriplegia
Cervical Spinal Cord Injury
Amyotrophic Lateral Sclerosis
Quadriplegia/Tetraplegia
Tetraplegic; Paralysis
Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 22 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 6 (estimated)
- Sponsor
- Neuralink Corp · Industry
Who this trial is looking for
This trial is looking for adults with severe speech impairment due to conditions like stroke or ALS. Participants will receive a device implanted in their brain to help restore communication abilities.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with ALS, PLS, stroke, or spinal cord injury.
- I have severe speech impairment.
- I have impaired upper limb function.
- I expect to live for at least 12 more months.
- I can communicate in English.
- I have a stable caregiver.
You may not be able to join if
- I am at moderate to high risk for serious perioperative adverse events.
- I have a Body Mass Index over 40.
- I have poorly controlled seizures or epilepsy.
- I have poorly controlled diabetes.
- I need an MRI for ongoing medical conditions.
- I have an acquired or hereditary immunosuppression.
- I have a psychiatric or psychological disorder.
- My brain MRI shows hemorrhage, tumor, or adverse anatomy.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
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 ce…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria
* Moderate to high risk …
Contacts