Speech Disorder
Conditions
Brief summary
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.
Interventions
DEVICEWRS
WRS 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.
Sponsors
Shanghai StairMed Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Device-Related Adverse Events | From implantation to Month 12 | Adverse events determined by the investigator to be related to the investigational device, recorded throughout the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of All Adverse Events | From implantation to Month 12 | — |
| Incidence of Device Deficiencies | From implantation to Month 12 | — |
| Number of Reliable Recording Channels at Each Evaluation Time Point | At 3, 6, 9, and 12 months post-implantation | — |
| Speech Output Rate in Characters Per Minute (CPM) | At 3, 6, 9, and 12 months post-implantation | 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. |
| Speech Output Character Error Rate (CER) | At 3, 6, 9, and 12 months post-implantation | The subject independently outputs the complete sequence of Chinese characters from a standard reference text. The minimum edit distance (total substitutions, deletions, and insertions) between the decoded sequence and the reference sequence is divided by the total number of Chinese characters in the reference text to obtain the character error rate. Recorded every 3 months during follow-up. |
Countries
China
Contacts
CONTACTClinical team Stairmed
Outcome results
None listed