Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation (WISE)
8 september 2026 bijgewerkt door: Shanghai StairMed Technology Co., Ltd.
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.
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Geschat)
4
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Clinical team Stairmed
- Telefoonnummer: +86 021-80510178
- E-mail: yumiao@stairmed.com
Studie Locaties
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China
- Werving
- Huashan Hospital, Fudan University
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Contact:
- Ying Mao, Ph.D
- Telefoonnummer: +86 021 5288 8045
- E-mail: maoying@fudan.edu.cn
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Toestel Haalbaarheid
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Implantation of the WRS
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of Device-Related Adverse Events
Tijdsspanne: From implantation to Month 12
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Adverse events determined by the investigator to be related to the investigational device, recorded throughout the study period.
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From implantation to Month 12
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of All Adverse Events
Tijdsspanne: From implantation to Month 12
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From implantation to Month 12
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Incidence of Device Deficiencies
Tijdsspanne: From implantation to Month 12
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From implantation to Month 12
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Number of Reliable Recording Channels at Each Evaluation Time Point
Tijdsspanne: At 3, 6, 9, and 12 months post-implantation
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At 3, 6, 9, and 12 months post-implantation
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Speech Output Rate in Characters Per Minute (CPM)
Tijdsspanne: At 3, 6, 9, and 12 months post-implantation
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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.
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At 3, 6, 9, and 12 months post-implantation
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Speech Output Character Error Rate (CER)
Tijdsspanne: At 3, 6, 9, and 12 months post-implantation
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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.
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At 3, 6, 9, and 12 months post-implantation
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2026
Primaire voltooiing (Geschat)
30 augustus 2028
Studie voltooiing (Geschat)
30 december 2028
Studieregistratiedata
Eerst ingediend
9 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 juni 2026
Eerst geplaatst (Werkelijk)
15 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 september 2026
Laatste update ingediend die voldeed aan QC-criteria
8 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STAIRSUP-201
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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