Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation (WISE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Speech Disorder
• Intervention / Treatment: Device: WRS

• Study Type: Interventional
• Enrollment (Estimated): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical team Stairmed; Phone Number: +86 021-80510178; Email: yumiao@stairmed.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Huashan Hospital, Fudan University
      • Contact: Ying Mao, Ph.D; Phone Number: +86 021 5288 8045; Email: maoying@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implantation of the WRS	Device: WRS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Device-Related Adverse Events	Adverse events determined by the investigator to be related to the investigational device, recorded throughout the study period.	From implantation to Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai StairMed Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Speech Disorders
• Other Study ID Numbers: STAIRSUP-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No