Wireless brain-implant that helps speech people communicate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm trial will implant a wireless BCI device and provide brain-control training to participants with speech disorders. Participants will be followed for 12 months to monitor safety, adverse events, and any evidence of brain-controlled communication. The study focuses on preliminary safety and potential effectiveness of the device in enabling brain-driven interaction for speech-impaired individuals. Data will include adverse events, device deficiencies, and measures of brain-controlled communication performance. The sponsor is Shanghai StairMed Technology Co., with site at Huashan Hospital, Fudan University in Shanghai.

Why it matters

Who can join: the full rules

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

Where it's running

• Huashan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Clinical team Stairmed
• Email: yumiao@stairmed.com
• Phone: +86 021-80510178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.