Clinical

Ecole Polytechnique Fédérale de Lausanne (EPFL) has launched a clinical study evaluating the preliminary safety and effectiveness of a cortical recording device (ECoG) combined with lumbar targeted epidural electrical stimulation (EES) to restore voluntary lower-limb motor function in participants with chronic spinal cord injury and mobility impairment. The study aims to establish a direct bridge between motor intention and the spinal cord below the lesion, potentially improving or restoring voluntary leg control and promoting neurological recovery when combined with neurorehabilitation.

Hospices Civils de Lyon has registered a clinical study in France to decode motor imagery from non-invasive brain recordings as a prerequisite for innovative motor rehabilitation therapies. Combining MRI, MEG, and EEG, the study will design a subject-specific neurophysiological model, noting that standard BCI approaches neglect transient features such as beta bursts. The approach will first be validated in healthy subjects, then assessed for feasibility in stroke patients.

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.

Surgeons in Michigan have implanted Paradromics' Connexus brain-computer interface in a patient with motor neuron disease who had lost most of her ability to speak. Connexus records from individual neurons through 421 microelectrodes seated 1.5 millimeters into the motor cortex; the signals pass to a transceiver in the patient's chest, where AI converts them into text on a screen. Austin, Texas-based Paradromics received FDA approval in the fall of 2025 to begin the 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.

Clinicians and researchers in Guangzhou, southern China, will get hands-on time with closed-loop systems that trigger transcranial magnetic stimulation from real-time EEG analysis at a workshop on July 17, 2026. Shenzhen Yingchi Technology, one of the supporting companies, will bring EEG-driven closed-loop TMS devices and near-infrared brain function imaging equipment. The session is organized by the Professional Committee on Brain Function Detection and Regulation Rehabilitation of the Chinese Association of Rehabilitation Medicine, alongside the committee's 2026 annual conference and the 8th Brain Function Detection and Regulation Rehabilitation Forum.

Grenoble University Hospital has registered a clinical study (NCT07698496) assessing the feasibility and effectiveness of a chronic brain-computer interface for speech rehabilitation in people with locked-in syndrome (LIS), where non-invasive communication carries high cognitive load and existing invasive speech BCIs still rely on percutaneous connectors with infection risk. Using an intracranial epidural BCI paired with a speech synthesizer, the SpeechBCI protocol will test two complementary approaches in the same subject — a speech BCI (primary objective, the BCI_PAROLE device) and a cursor BCI (secondary), both running on the WIMAGINE intracranial epidural system. The trial is in the registration stage and has no clinical 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.

The trial compares motor imagery BCI plus standard rehabilitation against standard rehabilitation alone in stroke patients with hemiplegia, tracking limb motor function and daily living ability. It planned to enroll 60 participants, 30 per arm, with the first participant enrolled on August 10, 2022; the registry now lists the study as completed. Beyond motor scales, the primary outcomes include functional connectivity and a lateralization index measured with fNIRS, probing brain-network changes rather than behavior scores alone.

In Xiangya Hospital's invasive IMIE smart retina trial, a 61-year-old fully blind patient reportedly reached 0.03 stable and 0.1 best visual acuity, walking indoors unaided.

The Chinese Clinical Trial Registry (ChiCTR) logged a new study on June 5, 2026 under the number ChiCTR2600126291, testing whether a period of multisensory embodied training beforehand alters the neural representation of imagined movement and the decoding performance of a brain-computer interface (BCI). Recruitment has not yet begun.

A newly registered trial tests a brain-computer interface in post-stroke rehabilitation across 4 parallel arms: full cross-domain (emotion-cognition-motor) adaptive training, integrated cognitive and motor task training, single-dimension motor training, and conventional rehabilitation. Each arm plans 22 participants, 88 in total. It enrolls patients aged 30 to 80 with a first cerebral infarction or hemorrhage 3 months to 1 year earlier, unilateral hemiplegia, and upper-limb Brunnstrom stage II to IV. The primary outcome is a motor function score; secondary outcomes include EEG motor imagery event-related synchronization/desynchronization, prefrontal theta/alpha power ratio, and EEG-fNIRS coupling.

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.

Onward Medical said the first participant in its global Empower BP pivotal study was enrolled and implanted with the investigational ARC-IM system at Craig Hospital in Denver during the first quarter of 2026. The randomized, double-blind, sham-controlled trial is evaluating management of blood-pressure instability after spinal cord injury across about 20 planned centers. Empower BP is not an upper-limb BCI trial, and the first implant did not take place in the Netherlands.

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.

Can a non-invasive brain-computer interface read motor intention and, combined with spinal cord stimulation and exoskeleton training, improve function after spinal cord injury? Xuanwu Hospital, Capital Medical University has registered a single-arm exploratory trial that plans to enroll 10 patients aged 18 to 65 with spinal cord injury. The intervention combines all three into one rehabilitation regimen. The primary outcome is the overall clinical efficacy rate 6 months after surgery; secondary outcomes include improvement in the Visual Analogue Scale for pain and the incidence of adverse events related to the trial devices.

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.

A Chinese team has registered a clinical trial of a multimodal brain-computer interface system for intelligent diagnosis and treatment, aimed at early screening and non-invasive modulation of Alzheimer's disease. The entry, ChiCTR2600125240, was filed with the Chinese Clinical Trial Registry on May 22, 2026 and is carried by the WHO International Clinical Trials Registry Platform; recruitment has not begun.

Burning mouth syndrome produces months or years of burning oral pain with no visible lesion on examination, and treatment options are limited, leaving patients shuttling between oral medicine and psychiatry. A randomized, sham-controlled interventional trial registered by Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, will apply transcranial direct current stimulation over the left dorsolateral prefrontal cortex while collecting resting-state brain function and structural imaging, tracking pain, anxiety, depression, sleep and salivary flow. The trial is funded by the hospital's Brain-Computer Interface Special Research Program and registered as ChiCTR2600124987 on May 20, 2026. It plans to enroll 38 participants, 19 in the active group and 19 in the sham group, with first enrollment set for June 1, 2026; recruitment has not yet started.

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.

Shandong Provincial Hospital in eastern China has registered a pilot trial that will test whether patients with acute ischemic stroke can begin brain-signal-driven arm training within days of onset. The planned 60 participants will practice upper-limb movements with a scalp EEG brain-computer interface that reads their intention to move and gives training feedback, compared against a sham-training group. Both groups will train for 10 days on top of standard early rehabilitation, twice a day for about 30 minutes per session. The primary outcome is the change in upper-limb motor function score 30 days after randomization. The trial is not yet recruiting and is expected to start in October 2026.

Guangdong Provincial Hospital of Traditional Chinese Medicine has registered a parallel-design interventional trial, ChiCTR2600124411, that plans to enroll 81 patients with unilateral upper-limb impairment after stroke in three groups of 27. Two groups receive intermittent theta-burst stimulation (iTBS) over the dorsolateral prefrontal cortex or the primary motor cortex, and one receives sham stimulation; all three undergo motor imagery BCI training. Primary outcomes are BCI decoding accuracy, the Fugl-Meyer Assessment and brain network topology. The trial was registered on May 12, 2026 and is not yet recruiting.