Trials

Shanghai-based StairMed has taken its wireless implantable brain-computer interface system into human evaluation for people with speech impairments. The prospective, single-arm trial (NCT07647315) actually began on September 1, 2026, is now recruiting, and plans to enroll 4 participants. Subjects will undergo surgical implantation and brain-control training, followed by an expected 12 months of follow-up recording adverse events, serious adverse events and device deficiencies, along with efficacy data on brain-controlled interaction and communication. Primary completion is expected on August 30, 2028, and the study as a whole on December 30, 2028. The registry record does not disclose the implant site, decoding method or detailed eligibility criteria, and no interim results have been posted, so conclusions on safety and efficacy will have to wait for follow-up data.

A multicenter cohort study aims to enroll 1,000 stroke patients, with the treatment arm receiving closed-loop BCI plus functional electrical stimulation rehabilitation and the control arm receiving conventional training. The primary endpoint is 2-week change in upper and lower limb FMA scores. First enrollment is scheduled for September 1, 2026.

The University of Aveiro in Portugal has registered a study (NCT07732868) testing a brain-machine interface protocol that pairs virtual reality with sensory feedback, visual, auditory and tactile, and/or an exoskeleton in people with spinal cord injury. Participants attend 12 monitored sessions, one a week, each lasting roughly one to two hours, moving a virtual avatar through motor imagery while non-invasive EEG records brain activity. The study focuses on changes in brain activity that track clinical improvement and on how information moves between brain regions, and it collects age, sex, injury level and type, time since injury, functional grade and neuropathic pain; it is at the registration stage with no results yet.

The VA Office of Research and Development is advancing a high-performance implanted brain-computer interface (BCI) to improve independence for Veterans and others with tetraplegia or inability to speak due to ALS, spinal cord injury, or stroke. The project enhances deep learning decoders and multi-state gesture decoding, deployed on a battery-powered mobile BCI device for independent home use of computers and touch-enabled devices. Accuracy and usability will be evaluated in participants already enrolled in the BrainGate investigational clinical trial.

The University of Texas at Austin has registered a study on ClinicalTrials.gov to explore whether an EEG-based brain-computer interface (BCI) decoding the P300 event-related potential in real time, combined with non-invasive interventions such as mindfulness relaxation or transcranial electrical stimulation, can enhance attention and memory neural markers—proxies for cognitive reserve—in healthy older adults and those with mild cognitive impairment (MCI). The trial is recruiting and aims to test whether targeted modulation of attention-related brain activity can support cognitive reserve.

NeuroXess registered a prospective, multicenter, single-arm trial (NCT07720882) enrolling people with tetraplegia caused by spinal cord injury to evaluate the safety and clinical efficacy of an implantable BCI system for compensatory hand movement and upper-limb functional replacement. The study is at the registration stage with no results yet.

The study involves no implant and tests no device. It asks 50 adults with acquired blindness what existing assistive devices get wrong, and what they would want from a vision-restoration implant. Outcomes span demographics and economics, quality of life, clinical features, satisfaction with current aids, and design requirements for an invasive visual brain-computer interface. Participants must be at least 18, have only weak or no light perception in both eyes, and have lost their sight after birth; congenital blindness is excluded.

Women with overactive bladder often rely on drugs and behavioral training, with limited relief. A newly registered trial at The First Affiliated Hospital of Soochow University takes a different route: patients perform a task while functional near-infrared spectroscopy reads prefrontal brain activity, and an algorithm decides when to deliver transcranial magnetic stimulation, closing the loop. The interventional, parallel-design trial plans to enroll 66 women aged 18 to 75, 33 in the experimental arm and 33 in a control arm that receives open-loop sham stimulation, with the overactive bladder symptom score as the primary endpoint. No device model or results are disclosed in the registration, and recruitment has not yet started.

The randomized controlled trial plans to enroll 60 patients with lower limb motor impairment after stroke, with the intervention group receiving BCI-assisted exoskeleton rehabilitation training and the control group conventional walking training. Primary outcomes include lower limb surface electromyography, lower limb motor function, the Modified Barthel Index, a balance scale and functional ambulation, testing whether a BCI-driven exoskeleton adds functional benefit over conventional gait training. Punan Hospital, Pudong New Area, Shanghai is the sponsor, with first enrolment set for May 30, 2026. The trial is registered with the Chinese Clinical Trial Registry (ChiCTR) under number ChiCTR2600125531, with a registration date of May 28, 2026, and recruitment has not yet started.

The Chinese Clinical Trial Registry (ChiCTR) has logged a study of how brain-computer interface training built on a motor imagery paradigm affects lower-limb motor function in stroke patients. Registered on May 28, 2026 as ChiCTR2600125562, the trial is recruiting; design, sample size and sponsor are absent from the record carried by the WHO International Clinical Trials Registry Platform (ICTRP) and must be read from the original ChiCTR entry.

The randomized controlled trial plans to enroll 58 patients with upper limb motor dysfunction after stroke. The test group will receive feedback-based rehabilitation training through brain-computer interface interaction, while the control group will undergo traditional upper limb circular motion training. The primary outcome is the Fugl-Meyer Motor Assessment-Upper Extremity (FMA-UE), with secondary outcomes covering motor function, daily living activities, quality of life and neurophysiological measures including EEG, transcranial magnetic stimulation and fNIRS. The trial was prospectively registered, with first enrolment set for June 1, 2026, and recruitment has not yet started.

The multicenter randomized controlled trial plans to enroll 222 patients who are 1 to 3 months past their first stroke and have motor impairment in the affected lower limb. The experimental group will receive 4 weeks of motor imagery-based BCI-driven active and passive lower limb training, while the control group gets 4 weeks of conventional training. The primary outcome is the Fugl-Meyer Assessment Lower Extremity Section, with balance, daily living ability and walking classification as secondary outcomes. First enrolment is set for May 31, 2026.

The multicenter randomized controlled trial pits closed-loop BCI ankle training against conventional active and passive ankle training in subacute stroke patients who are 4 to 12 weeks past onset and have less than 10 degrees of active ankle dorsiflexion. Primary endpoints are active ankle dorsiflexion range of motion and Manual Muscle Testing of the ankle; secondary endpoints include Functional Ambulation Classification, the Berg Balance Scale and the Fugl-Meyer Motor Assessment of the Lower Limb. The trial plans to enroll 120 patients, 60 per arm, with first enrolment set for May 31, 2026.

The trial tests whether a steady-state visual evoked potential (SSVEP) brain-computer interface can drive functional electrical stimulation of swallowing muscles more effectively than conventional neuromuscular electrical stimulation. It plans to enroll 90 patients, 45 per arm, all within 6 months of a first ischemic or hemorrhagic stroke and aged 18 to 80. The primary outcome is the Standard Swallowing Assessment, with secondary measures including the Functional Oral Intake Scale and the Penetration-Aspiration Scale. First enrollment is listed for June 1, 2026.

A trial combining tactile-feedback brain-computer interface training with motor imagery for upper-limb rehabilitation after stroke is recruiting in China. Registered with the Chinese Clinical Trial Registry as ChiCTR2600124911 on May 19, 2026 and carried by the WHO International Clinical Trials Registry Platform, the trial record is available through the WHO International Clinical Trials Registry Platform.

The trial split 54 stroke patients with hand impairment into three groups using kinesthetic, hybrid and visuomotor imagery to drive BCI training, with upper-limb Fugl-Meyer score as the primary endpoint. The registration record does not yet report which imagery mode worked best.

A trial at Xuzhou Rehabilitation Hospital Affiliated to Xuzhou Medical University paired a motor imagery brain-computer interface with modified constraint-induced movement therapy to restore upper-limb function after stroke. The hospital is a rehabilitation specialty facility affiliated with Xuzhou Medical University, and the combined approach is meant to test whether a BCI adds benefit on top of established rehabilitation training. It planned 40 participants, 20 in the combined group and 20 in the control group, with the first patient enrolled on December 24, 2025; the registry now lists the study as completed. The primary endpoint is the Fugl-Meyer Assessment for Upper Extremity, with the Wolf Motor Function Test and modified Barthel Index as secondary measures. Funding comes from the New Round of Xuzhou "Pengcheng Talent Program" — High-level Healthcare Talent Recruitment and Development Project, project number 2025TD14. No results are posted, so whether the combined approach beats constraint therapy alone remains unknown.

A randomized, sham-controlled trial will pair a non-invasive brain-computer interface with MRI-guided multichannel temporal interference stimulation in patients whose migraines resist medication. It plans to enroll 78 people aged 18 to 65, split evenly between real and sham stimulation, with headache frequency as the primary endpoint. The registration lists only design and bibliographic fields, so device details and actual enrollment remain unknown and efficacy has yet to be read out.

A trial registered with the Chinese Clinical Trial Registry combines low-frequency rTMS with motor imagery brain-computer interface therapy, using conventional physical rehabilitation as the control, with the Fugl-Meyer upper extremity scale as the primary endpoint. The study has three parts: Part I compares BCI therapy with conventional rehabilitation, while Part III compares three rTMS protocols. It plans to enroll 213 participants, with first enrolment set for May 1, 2026; recruitment has not yet begun.

A trial of a dual-task brain-computer interface (BCI) combining motor-intention detection with virtual reality training is recruiting patients to measure how it affects shoulder function after rotator cuff repair surgery, following its registration with the Chinese Clinical Trial Registry (ChiCTR) on April 20, 2026. The record has been reposted by the WHO International Clinical Trials Registry Platform (ICTRP).

A new entry in the Chinese Clinical Trial Registry covers a study using brain-computer interface technology for functional recovery after stroke. The record, ChiCTR2600120924, was posted on March 23, 2026, and lists its status as not yet recruiting. The registry listing carries only bibliographic details, so the trial design, sample size and sponsor remain undisclosed.

The University of Miami is recruiting participants with incomplete spinal cord injury for a walking rehabilitation trial combining a brain-computer interface with transcutaneous spinal cord stimulation. The trial is registered on ClinicalTrials.gov as NCT06406855 and is currently recruiting.

The University of Texas at Austin has registered a study on ClinicalTrials.gov, NCT05907343, testing whether non-invasive stimulation can strengthen cognitive control in older adults, enrolling both people with cognitive impairment and people without it. It asks whether theta burst stimulation, a form of transcranial magnetic stimulation, can restore a range of cognitive functions, and whether delivering it in closed loop, timed to ongoing brain activity rather than on a fixed schedule, changes the result.

The VA Office of Research and Development is conducting a clinical trial to characterize proprioceptive sensations in the missing limb of upper limb amputees using nerve stimulation and to develop advanced controllers for moving a prosthesis. The trial uses Functional Electrical Stimulation (FES), applying small electric currents to the nerves, and tests different stimulation placements. The trial is registered as NCT04947462 and is currently recruiting.

Johns Hopkins University is conducting an early feasibility study to evaluate the safety and efficacy of the Bidirectional Cortical Neuroprosthetic System (BiCNS). The system comprises NeuroPort Microelectrode Array Systems, NeuroPort Electrodes (Sputtered Iridium Oxide Film), Patient Pedestals, the NeuroPort BioPotential Signal Processing System, and the CereStim C96 Programmable Stimulator. The trial enrolls patients with tetraplegia and quadriplegia and is currently recruiting.