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RecruitingNCT07647315WISEUpdated Sep 11, 2026

Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation

An interventional study of WRS in Speech Disorder, sponsored by Shanghai StairMed Technology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Shanghai StairMed Technology Co., Ltd. · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Speech Disorder

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03

In context

Speech Disorders

77 studies on the registry are indexed under Speech Disorders; 20 are open to participants now.

This study's planned enrollment of 4 is below the median of 38 across 54 interventional studies indexed under Speech Disorders.

Browse Speech Disorders studies →

Lead sponsor

Shanghai StairMed Technology Co., Ltd. is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form

Exclusion criteria

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 disorders (e.g., aplastic anemia, systemic lupus erythematosus); or subjects with 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (estimated)

Study arms

  • Experimental
    Implantation of the WRS

    Device: WRS

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.

06

What researchers measure

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 12

Secondary outcomes

  1. Incidence of All Adverse Events

    Time frame: From implantation to Month 12

  2. Incidence of Device Deficiencies

    Time frame: From implantation to Month 12

  3. Number of Reliable Recording Channels at Each Evaluation Time Point

    Time frame: At 3, 6, 9, and 12 months post-implantation

  4. 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-implantation

  5. Speech Output Character Error Rate (CER)

    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.

    Time frame: At 3, 6, 9, and 12 months post-implantation

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07647315
Lead sponsor
Shanghai StairMed Technology Co., Ltd.
Responsible party
Sponsor
First posted
Jun 15, 2026
Start date
Sep 1, 2026
Primary completion
Aug 30, 2028 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Clinical team Stairmed
Contact
yumiao@stairmed.com
+86 021-80510178

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Shanghai StairMed Technology Co., Ltd.

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