Speech DisorderWISENCT07647315
Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation
A study testing WRS in people with Speech Disorder, run by Shanghai StairMed Technology Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Speech Disorder
- What is being tested?
- WRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality
Ying Mao, Ph.D, +86 021 5288 8045, maoying@fudan.edu.cn
About this study
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.
- Conditions
- Speech Disorder
- Being tested
- WRS
- Medical subject headings
- Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WRSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Implantation of the WRS | Experimental | Not described Receives: Device: WRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Device-Related Adverse Events
Adverse events determined by the investigator to be related to the investigational device, recorded throughout the study period.
Measured: From implantation to Month 12
Secondary outcomes (5)
Incidence of All Adverse Events
Measured: From implantation to Month 12
Incidence of Device Deficiencies
Measured: From implantation to Month 12
Number of Reliable Recording Channels at Each Evaluation Time Point
Measured: At 3, 6, 9, and 12 months post-implantation
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.
Measured: At 3, 6, 9, and 12 months post-implantation
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.
Measured: At 3, 6, 9, and 12 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Sep 2026
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai StairMed Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647315
- Sponsor's protocol ID
- STAIRSUP-201
- Acronym
- WISE
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation
- ClinicalTrials.gov ID
- NCT07647315
- Acronym / sponsor ID
- WISE / STAIRSUP-201
- Conditions
- Speech Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Shanghai StairMed Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of the WRS | Experimental | Device: WRS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WRSWRS 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. | Device | Implantation of the WRS |
Primary outcome
Incidence of Device-Related Adverse Events
Time frame: From implantation to Month 12
Adverse events determined by the investigator to be related to the investigational device, recorded throughout the study period.
5 secondary outcomes
Incidence of All Adverse Events
Time frame: From implantation to Month 12
Incidence of Device Deficiencies
Time frame: From implantation to Month 12
Number of Reliable Recording Channels at Each Evaluation Time Point
Time frame: At 3, 6, 9, and 12 months post-implantation
Speech Output Rate in Characters Per Minute (CPM)
Time frame: At 3, 6, 9, and 12 months post-implantation
Speech Output Character Error Rate (CER)
Time frame: At 3, 6, 9, and 12 months post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WRS in people with Speech Disorder, run by Shanghai StairMed Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical team Stairmed (+86 021-80510178, yumiao@stairmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Device-Related Adverse Events (time frame: From implantation to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.