Mind-Reading chip aims to give voice to the speechless
NCT ID NCT07647315
First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This early study tests a small, wireless brain implant designed to help people with severe speech problems communicate by thought. Four adults with conditions like locked-in syndrome or ALS will get the implant and learn to control it. The main goal is to see if the device is safe and can reliably turn brain signals into communication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- WRS wireless brain-computer interface device
- What this could lead to
- If it works, this could give people who cannot speak a new way to communicate using only their thoughts.
- What could go wrong
- This is a very early, tiny trial with only 4 people. The device requires brain surgery, and it is not yet known if it will work reliably or be safe long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 4 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 to 80 years (inclusive), any gender. * Clinically diagnosed with speech disorders, including locked-in syndrome, severe dysarthria, aphasia with preserved auditory comprehension, or late-stage ALS-related language dysfunction, secondary to stroke, traumatic brain injury, amyotrophic lateral sclerosis (ALS), or other motor neuron diseases. * The subject, or the subject with the assistance of their legal representative, is willing to follow the investigator's instructions, adhere to all protocol-specified procedures, and complete all required follow-up. * The subject and their legal representative fully understand the purpose and significance of the trial; the subject voluntarily agrees to participate and signs the informed consent form Exclusion Criteria: * Subjects with any previously implanted metallic objects or devices (e.g., pacemakers, defibrillators, neurostimulators, cochlear implants), except for dental metal implants or implants assessed to have no impact on the trial. * Subjects who have been on long-term anticoagulant or antiplatelet therapy prior to screening, with antiplatelet drugs discontinued for less than 2 weeks before surgery; or subjects with hematological or autoimmune disorders (e.g., aplastic anemia, systemic lupus erythematosus); or subjects with clinically significant coagulation test abnormalities during the screening period. * Subjects assessed by an anesthesiologist to be unable to tolerate anesthesia and surgery. * Subjects assessed by the investigator to have nervous system diseases (e.g., cerebrovascular lesions, intracranial infections, neurodegenerative diseases, epilepsy) or a history of craniocerebral trauma, resulting in severe brain function impairment or marked EEG abnormalities. * Subjects with physiological or pathological conditions that may lead to poor healing of scalp wounds. * Subjects in the acute infection phase or suffering from other severe infections. * Subjects with cognitive impairment or psychotic symptoms. * Subjects with severe dysfunction of vital organs (heart, lung, liver, kidney, etc.), malignant tumors or autoimmune diseases, who are deemed ineligible for this clinical trial by investigators. * Subjects judged by investigators to have an expected survival time of less than 1 year. * Subjects with drug abuse or alcohol dependence. * Pregnant or breastfeeding women, or subjects planning to become pregnant during the trial period. * Subjects currently participating in clinical trials of drugs or other medical devices. * Subjects unable to understand or read Chinese. * Other circumstances under which investigators consider the subject unsuitable to participate in this clinical trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Huashan Hospital, Fudan University
RECRUITINGShanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.