An interventional study of Endovascular Venous BCI Type-A Sensor and BCI-Triggered Functional Electrical Stimulation in Stroke, Hemiplegia and Spinal Cord Injury, sponsored by Wei Wu. Not yet recruiting at 1 site in China. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Wei Wu · Not applicable, Interventional, and Device feasibility
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Among 611 studies in Stroke with a site in China — 240 open to participants now, 261 under way, 21 of them phase 3. Stroke · China.
Among the 611 studies in Stroke with a site in China, this one is the 418th largest by planned enrollment of the 431 interventional ones that give a count, is one of 64 that started in 2026, is one of 263 with no phase, reaches primary completion later than 167 of the 260 other live ones, and was the 611th registered.
8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.
Browse Stroke studies →240 of the 611 studies in Stroke with a site in China are open now. Recruiting first, the newest first:
Beijing Pins Medical Co., Ltd · Sites in China
Ages 18–75
Capital Medical University · Sites in China
Ages 18–80
Capital Medical University · Sites in China
Ages 18+
Beijing Tiantan Hospital · Sites in China
Ages 12–70
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.
This study: 20 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
611 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 47 · Phase 3 72 · Phase 4 42
First in 2000; this study’s year is marked. 64 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 2 is below the median of 49 across 6,027 interventional studies indexed under Stroke.
Median enrollment 170 across the 431 interventional studies, 622 across the 179 observational. Of the 211 that completed or were terminated, 31 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
51 of 611 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Wei Wu as lead sponsor.
Wei Wu has 1 study filed under Stroke — fewer than ten, so there is no comparison to draw.
67 of the studies in Stroke with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05976152Phase 3Fudan UniversityEffect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER) | 2026-12 |
| NCT06658197Phase 3Xuanwu Hospital, BeijingEfficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke | 2026-12-01 |
| NCT06954155Phase 3Beijing Tiantan HospitalTenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND | 2027-02-28 |
| NCT07002476Phase 3Shanghai East HospitalEarly Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion | 2027-03-01 |
| NCT07603102Nanjing Mingzhou Rehabilitation HospitalMindfulness With Dual-Task Training in Post-Stroke Mild Cognitive Impairment | 2026-11 |
Add all 67 to your calendar (.ics) → With an account.
Among the 611 studies in Stroke with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study tests the safety and feasibility of a new type of brain-computer interface (BCI) in people with severe paralysis caused by stroke, spinal cord injury, or amyotrophic lateral sclerosis (ALS). A BCI records signals directly from the brain and uses them to control external devices. In this study, a small stent-shaped sensor (a metal mesh tube carrying tiny electrodes) is placed inside a vein on the surface of the brain through a needle puncture in a large vein below the collarbone, so no open-brain surgery is needed. Once in place, the sensor records brain activity while participants imagine or attempt movements.
Two participants will be enrolled. One participant with stroke-related arm paralysis who still has rehabilitation potential will receive closed-loop functional electrical stimulation (FES): when the BCI detects the intention to move the paralyzed hand, electrical pulses are delivered to the arm muscles, producing real movement and sensory feedback. This pairing of intention and movement may help the brain rebuild damaged pathways. The other participant with ALS or severe paraplegia and no realistic chance of recovering voluntary movement will use the same sensor to control a robotic arm that helps perform daily tasks such as eating, grasping objects, and opening a door.
For both participants, the study lasts about 60 days after sensor implantation. Training sessions last 45 minutes per day during weeks 2 to 4. Imaging (brain CT and CT venography), electroencephalography (EEG), blood tests, and movement or daily-living assessments are performed at regular intervals. After the week-4 evaluation, the sensor is either removed (short-term group) or left in place for continued monitoring (long-term group), based on the participant's own choice made before enrollment and on clinical judgment. The main measures are safety (side effects, blood clots, bleeding, device problems), quality of the recorded brain signals, accuracy of decoding movement intention, and improvement in arm function or daily-task performance.
Study design and schedule. This is an investigator-initiated, single-center, exploratory, paired one-to-one study. Each participant undergoes the following schedule: screening and baseline assessments (including MRI, MRV/CTV, task-state fMRI or magnetoencephalography, 24-hour EEG, SWI-MRI, and laboratory tests); dual antiplatelet therapy (aspirin 100 mg once daily plus clopidogrel 75 mg once daily) starting 2 weeks before implantation and continuing for 3 months; endovascular implantation under general anesthesia; decoder calibration during post-implantation week 1; task-specific closed-loop training (FES for the rehabilitation group, robotic arm for the assistance group) during weeks 2 to 4; and follow-up with assessments on post-implantation days 1, 7, 14, 30, and 60.
Device. The endovascular venous BCI Type-A sensor is a self-expanding nitinol stent (diameter 6 mm) carrying pure platinum electrodes (300 micrometers in diameter, 50 micrometers thick). It is delivered through the subclavian vein into the superior sagittal sinus or a cortical vein overlying the hand area of the motor cortex, using fusion of 3-dimensional venography with MRI for targeting. The sensor is connected to a chest-wall implanted relay and telemetry unit.
Safety monitoring. Brain CT is performed immediately and 24 hours after implantation; CT venography and EEG are repeated at scheduled visits; vital signs are monitored every 15 minutes for the first 4 hours after implantation. Adverse events are coded with MedDRA 24.1 and reported to the Ethics Committee. Participation of an individual will be stopped if cerebral hemorrhage, cerebral infarction, cerebral venous sinus thrombosis, or status epilepticus occurs.
Statistics. This is an exploratory feasibility study of 2 participants; no hypothesis of therapeutic superiority will be tested. Continuous variables will be described as mean +/- standard deviation or median (interquartile range); categorical variables as counts and percentages. Missing data will not be imputed. Decoding models will be evaluated by 5-fold cross-validation.
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.
post-stroke hemiplegia, paraplegia due to spinal cord injury, or ALS (limb-onset spinal type or progressive muscular atrophy type)
Exclusion Criteria:
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with post-stroke hemiplegia who still have rehabilitation potential. After endovascular implantation of the venous BCI Type-A sensor, they receive decoder calibration during week 1, followed by daily 45-minute closed-loop functional electrical stimulation (FES) training during weeks 2 to 4, in which imagined or attempted hand movements decoded from brain signals trigger electrical stimulation of the paralyzed forearm muscles with real-time visual feedback. Stimulation intensity is adjusted dynamically, with a mandatory 2-minute rest every 10 minutes.
Device: Endovascular Venous BCI Type-A Sensor · Device: BCI-Triggered Functional Electrical Stimulation
Participants with ALS or severe paraplegia with no realistic prospect of recovering voluntary movement. After endovascular implantation of the venous BCI Type-A sensor, they complete decoder calibration during week 1, followed by daily 45-minute robotic arm training during weeks 2 to 4, in which decoded movement intention is used to control a bionic robotic arm for simulated daily tasks such as eating, grasping objects, and opening a door.
Device: Endovascular Venous BCI Type-A Sensor · Device: BCI-Controlled Bionic Robotic Arm
A self-expanding nitinol stent (diameter 6 mm) carrying pure platinum electrodes, implanted under general anesthesia via the subclavian vein into the superior sagittal sinus or a cortical vein overlying the hand area of the motor cortex, using fusion of 3-dimensional venography with MRI for targeting. The sensor is connected to a chest-wall implanted relay and telemetry unit for wireless signal transmission.
Closed-loop functional electrical stimulation of the paralyzed forearm muscles, triggered in real time by decoded movement intention. Daily 45-minute sessions during post-implantation weeks 2 to 4.
A bionic robotic arm controlled by decoded movement intention, used to perform simulated daily tasks. Daily 45-minute training sessions during post-implantation weeks 2 to 4. Response latency, task success rate, and false trigger rate are recorded.
Incidence of Treatment-Emergent Adverse Events
Number and percentage of participants with treatment-emergent adverse events, including device- or procedure-related events such as cerebral venous sinus thrombosis, cerebral hemorrhage or infarction, device migration, infection, and epileptiform discharges. Events are coded with MedDRA version 24.1.
Time frame: From sensor implantation through post-implantation day 60
Device Technical Success Rate
Number and percentage of participants in whom the endovascular venous BCI Type-A sensor is successfully deployed in the target venous sinus and remains functional (wireless signal transmission) through post-implantation day 60.
Time frame: Sensor implantation through post-implantation day 60
Effective Signal Bandwidth of the Endovascular Sensor
Effective bandwidth of neural signals recorded by the endovascular venous BCI Type-A sensor, in hertz (Hz), assessed by power spectral analysis of recorded signals. Higher values indicate better signal fidelity.
Time frame: Each recording session from the first post-implantation recording through day 60
BCI Decoding Trigger Success Rate
Percentage of successfully triggered system commands in 10 randomly selected motor-imagery tasks per assessment session (protocol-defined target \>=90%). Higher percentages indicate better decoding performance.
Time frame: Post-implantation weeks 1 to 4
Change in Motor Cortex Activation Volume on fMRI or MEG (Rehabilitation Group)
Change in activation volume of upper-limb motor areas during motor tasks on functional MRI or magnetoencephalography (activation volume in cubic centimeters; greater volume indicates greater activation; protocol target \>=15% increase).
Time frame: Baseline and monthly through day 60
Change in Barthel Index Score
Change in Barthel Index score from baseline, a measure of activities of daily living (range 0-100; higher scores indicate greater independence).
Time frame: Baseline and post-implantation days 7, 14, 30, and 60
Change in SF-36 Quality-of-Life Score
Change in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) scores from baseline. (Scale and summary scores range 0-100; higher scores indicate better health-related quality of life)
Time frame: Baseline and post-implantation days 14, 30, and 60
Quantitative EEG Indices
Relative band power of delta, theta, alpha, and beta bands; relative alpha variability; and cerebral state index derived from quantitative electroencephalography. Each index is reported separately.
Time frame: Baseline (24-hour EEG) and post-implantation days 7, 14, 30, and 60
Glasgow Outcome Scale Score
Glasgow Outcome Scale score at the end of follow-up (range 1-5; higher scores indicate better neurological outcome; GOS 1-3 unfavorable, GOS 4-5 favorable).
Time frame: Post-implantation day 60
Change in Surface EMG Integral Value of Flexor Carpi Radialis (Rehabilitation Group)
Change in integral surface electromyography value (in microvolt-seconds) of the affected flexor carpi radialis, reflecting muscle recruitment (protocol target \>=50% increase; higher values indicate greater muscle recruitment).
Time frame: Baseline through day 60, assessed weekly
Change in NIHSS Score
Change in National Institutes of Health Stroke Scale total score from baseline (range 0-42; higher scores indicate more severe neurological impairment).
Time frame: Baseline and post-implantation days 7, 14, 30, and 60
BCI Decoding False-Trigger Rate
Percentage of triggered commands classified as false triggers (lower percentages indicate better decoding specificity).
Time frame: Post-implantation weeks 1 to 4
Electrode Impedance
Electrode impedance of the endovascular sensor in ohms, measured monthly. Lower impedance indicates better electrode-tissue contact.
Time frame: Monthly through post-implantation day 60
Data Loss Rate
Percentage of recording data lost or discarded per session. Lower percentages indicate more reliable data acquisition.
Time frame: Each recording session through post-implantation day 60
Inter-Channel Signal Consistency
Consistency of signal amplitude across electrode channels, expressed as an inter-channel correlation coefficient (range 0-1; higher values indicate greater consistency).
Time frame: Monthly through post-implantation day 60
Change in Affected Upper-Limb Muscle Strength Grade (Rehabilitation Group)
Change from baseline, assessed by manual muscle testing (Medical Research Council scale, 0-5; higher grades indicate greater strength). Protocol target: improvement of at least 1 grade.
Time frame: Baseline and post-implantation days 7, 14, 30, and 60
Change in Fugl-Meyer Assessment Upper-Extremity Score (Rehabilitation Group)
Change from baseline (0-34 points as specified in the protocol; higher scores indicate better upper-limb motor function). Protocol target: increase of at least 40%.
Time frame: Baseline and post-implantation days 7, 14, 30, and 60
Change in Wolf Motor Function Test Completion Time (Rehabilitation Group)
Change from baseline under the assisted condition, in seconds (no fixed range; shorter times indicate better performance). Protocol target: reduction of at least 10%.
Time frame: Baseline and post-implantation days 7, 14, 30, and 60
Success Rate of Key Daily-Living Tasks With the BCI-Controlled Robotic Arm (Assistance Group)
Percentage of key daily tasks (eating, opening a door, grasping objects) successfully completed using the robotic arm (0-100%; higher percentages indicate better task performance). Protocol target: at least 80%.
Time frame: Post-implantation weeks 2 to 4, and days 30 and 60
Training Compliance Rate
Percentage of planned training sessions completed, recorded in training logs.
Time frame: Post-implantation weeks 1 to 4
Change in Hospital Anxiety and Depression Scale (HADS) Total Score
Change from baseline. The HADS is a 14-item self-report questionnaire with anxiety and depression subscales, each scored 0 to 21 (total 0-42); higher scores indicate worse anxiety and depressive symptoms.
Time frame: Baseline and post-implantation days 30 and 60
Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST 2.0) Score
Satisfaction with the assistive technology system assessed by the QUEST 2.0, a 12-item questionnaire scored on a 5-point satisfaction scale (1 = not satisfied at all to 5 = very satisfied); higher scores indicate greater satisfaction.
Time frame: Post-implantation days 30 and 60
Plan to share: No
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 3,111 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 7 months is below that.
Counting every sponsor, half of 3,255 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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