Trials

KK Women's and Children's Hospital in Singapore has registered a clinical trial of brain-computer interface neurofeedback training (BCI-NFT) for children and adolescents aged 7 to 21 with acquired brain injury from causes including traumatic brain injury, stroke, encephalitis, brain tumors and epilepsy. The intervention group will complete 12 sessions of about 60 minutes each over 10 weeks, wearing a wireless EEG headband while interacting with neurofeedback computer games; the control group receives standard care first and then crosses over to training. A cohort of peers with no history of brain injury will provide normative EEG data. The trial plans to enroll 70 participants, with primary endpoint results expected in February 2028.

The study asks whether adding closed-loop BCI exoskeleton training to conventional rehabilitation improves lower-limb recovery in stroke patients. The retrospective cohort plans to enroll 58 patients in a closed-loop training group and 57 in a conventional rehabilitation group, with the primary endpoint being change in FMA-LE score from baseline to week 6. Secondary outcomes include motor imagery-related EEG features, the 10-Meter Walk Test and the Berg Balance Scale, indicating the researchers want to track both walking function and the brain signals themselves. The trial is self-funded by the research team and has not yet begun recruiting.

About 70% to 80% of stroke survivors cannot live independently because of physical disability, and regaining walking function is central to changing that. This observational, cross-sectional study plans to enroll 200 stroke patients and 200 healthy controls, collecting EEG, fNIRS, sEMG, fMRI and other central and peripheral physiological signals alongside clinical measures such as Facial Action Units, the Berg Balance Scale and Fugl-Meyer motor function. The goal is a reusable non-invasive BCI dataset for stroke rehabilitation research. First enrollment is set for October 1, 2026.

BCIFlex Medical Technology has begun a clinical trial in China evaluating the safety and efficacy of an implantable wireless brain-computer interface in patients left tetraplegic by spinal cord injury. The trial is registered on ClinicalTrials.gov as NCT07784088 and is recruiting. The sponsor is a Chinese device maker headquartered in the Haidian district of Beijing with an office in Shanghai, working on invasive ultra-thin flexible electrodes; its products include digital EEG systems and stereo-EEG depth electrodes.

National University Hospital in Singapore has registered a clinical trial (NCT07784920) evaluating Lifescapes, an EEG-based brain-computer interface, for hand motor recovery after stroke. The 32-participant study, not yet recruiting, will compare Lifescapes therapy delivered with reduced therapist supervision against conventional rehabilitation and assess whether it is operationally feasible in the local clinical setting. Lifescapes combines motor imagery practice, biofeedback, neuromuscular electrical stimulation and robotic assistance for stroke patients with severe hand paralysis; an earlier trial in 40 patients showed improvement in motor function.

A multicenter trial has begun in China to test closed-loop brain-computer interface neuromodulation for treatment-resistant depression, run jointly by the Shanghai Mental Health Center and two Beijing hospitals, Anding Hospital and Xuanwu Hospital. The study will compare closed-loop deep brain stimulation and transcutaneous auricular vagus nerve stimulation against sham stimulation, enrolling patients who have responded inadequately to standard antidepressant treatment. It uses a patient-preference design with randomized assignment within each intervention group.

A new clinical trial at Brazil's Santos Dumont Institute will test whether brain-computer interface (BCI)-guided functional electrical stimulation (FES) can improve muscle activation and gait in people with spinal cord injury. The institute is a well-known Brazilian center for neurorehabilitation research. Registered on ClinicalTrials.gov as NCT07768930 and first posted on August 17, 2026, the study is active but not yet recruiting. The intervention involves ankle dorsiflexion rehabilitation: patients wear an EEG cap, the system detects motor-imagery-related brain signals in real time, and when an intention is detected, it triggers FES to stimulate the tibialis anterior muscle to assist ankle dorsiflexion. Primary outcomes are improvements in muscle activation patterns and gait kinematics. The trial is at an early stage, with enrollment details not yet disclosed.

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.

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.

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.

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 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 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 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.

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 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 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.

The trial plans to enroll 40 patients with Parkinson's disease aged 40 to 80, randomized into 2 groups: one adds brain-computer interface rehabilitation training to functional electrical stimulation, the other receives functional electrical stimulation alone. Both arms train 20 minutes per day for the upper extremities and 20 minutes per day for the lower extremities, completing 12 treatment days within 2 weeks. The primary endpoint is a motor symptom rating scale, with diffusion tensor imaging, magnetic resonance spectroscopy, resting-state fMRI, and sleep, cognitive and mood scales as secondary endpoints, testing whether adding BCI training produces measurable change beyond motor symptoms.

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 trial testing a brain-computer interface (BCI) combined with transcranial direct current stimulation (tDCS) in patients with disorders of consciousness was registered with the Chinese Clinical Trial Registry (ChiCTR) on May 7, 2026 under the number ChiCTR2600124127, and is now recruiting. The design, sample size and sponsor are not given in the record and would have to be checked against the original registration.

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.