Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation
ConditionSpeech Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai StairMed Technology Co., Ltd.
About this trial
This prospective, single-arm clinical trial is designed to preliminarily evaluate the safety and efficacy of an implantable wireless brain-computer interface (BCI) system (manufactured by Shanghai StairMed Technology Co., Ltd.) in enabling subjects with speech disorders to achieve brain-controlled interaction and communication. Eligible subjects will undergo surgical implantation of the device and receive brain-control training. All participants will be followed for an expected period of 12 months. During the follow-up, adverse events, serious adverse events, and device deficiencies will be recorded, and efficacy data on brain-controlled interaction and communication will be collected. The goal is to conduct an initial assessment of the safety and effectiveness of the investigational device in achieving brain-controlled effects in the target population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
WRS
DeviceWRS is a minimally invasive, wireless brain-machine interface system. Subjects with speech disorders undergo implantation of WRS, receive brain-control training, and are followed up.
Treatment groups
4 Participants
are divided into 1 treatment groupGroup A: Implantation of the WRSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Device-Related Adverse Events
Adverse events determined by the investigator to be related to the investigational device, recorded throughout the study period.
Time frame
From implantation to Month 12Secondary outcomes
1
Incidence of All Adverse Events
Time frame
From implantation to Month 122
Incidence of Device Deficiencies
Time frame
From implantation to Month 123
Number of Reliable Recording Channels at Each Evaluation Time Point
Time frame
At 3, 6, 9, and 12 months post-implantation4
Speech Output Rate in Characters Per Minute (CPM)
The speech output rate, defined as the number of Chinese characters produced per unit time during task performance, is calculated and documented every 3 months during the follow-up period.
Time frame
At 3, 6, 9, and 12 months post-implantationSponsors and contacts
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Source ClinicalTrials.gov