Trials

An ongoing randomized clinical trial will compare continuous neurofeedback with feedback indicating correct or incorrect task performance to assess learning and control of a motor imagery brain-computer interface in adults with subacute left-hemisphere stroke. The study in Argentina plans to enroll 20 participants and is enrolling by invitation. Participants will be randomly assigned to groups and receive BCI calibration followed by 10 real-time training sessions, with EEG and surface EMG recorded throughout. Decoding accuracy, algorithmic assistance, and motor and neurophysiological measures will be used to assess feasibility and performance for upper-limb rehabilitation. No results are available to establish benefits for BCI control or arm function.

A registered study that is not yet recruiting will compare a wearable brain-computer interface communication device with the eye-tracking devices already used by people with ALS. It plans to enroll 30 adults who use Tobii Dynavox or Smartbox eye-tracking devices. Each participant will try three options at home over 12 weeks: their own eye-tracking device and Cognixion ONE with either a head-worn augmented-reality display or a screen-based display. The main measure is the time participants voluntarily choose to use each option. Additional measures include communication speed, accuracy, and caregiver burden. No results are available. Cognixion ONE is investigational and is not FDA-approved or cleared for any medical use.

A registered observational case-control study plans to explore objective assessment of subjective tinnitus using non-invasive brain-computer interface technology. It aims to enroll 150 people with chronic tinnitus and 150 healthy controls. The primary outcome is auditory event-related potentials, brain electrical responses associated with sound events. Secondary measures include tinnitus handicap, anxiety and depression scale scores, pure-tone thresholds, noise exposure, and medication history. Controls will be matched to patients by age and other relevant characteristics, and neither group will receive an intervention. Recruitment is pending; the study does not yet establish diagnostic accuracy or treatment effects.

After a stroke, can the brain's intent to move still drive arm rehabilitation? A trial registered by Tan Tock Seng Hospital will read scalp EEG as acute stroke patients attempt movement and use those signals to trigger functional electrical stimulation of the arm. The study focuses on how these brain signals change over time after stroke and what that means for BCI-based rehabilitation. It plans to enroll 12 patients, is not yet recruiting, and expects primary completion in December 2027.

The First Affiliated Hospital of Bengbu Medical University, in eastern China's Anhui province, is recruiting for a clinical trial that uses brain-computer interface (BCI) neurofeedback to treat the cognitive-control deficits that keep people with internet gaming disorder from stopping play. The system reads frontal midline theta rhythms and feeds them back in real time so participants learn to regulate their own brain activity, with social rewards built in as reinforcers to improve efficacy and adherence. The trial plans to enroll 120 patients across three arms: dual-target neurofeedback plus social reward, neurofeedback alone, and sham feedback. Primary completion is expected on December 30, 2028.

A study investigating brain-computer interface training combined with a lower-limb exoskeleton for walking difficulties after stroke is listed as completed. It compares conventional rehabilitation alone, rehabilitation plus exoskeleton training, and rehabilitation plus combined BCI and exoskeleton training. Each group has a target of 20 participants, not a confirmed actual enrollment figure. The primary assessment concerns lower-limb motor function; other measures cover EEG, balance, and walking ability. First enrollment was dated 2024-03-22, before registration on 2026-09-23, making registration non-prospective. The registry contains no results, so it does not establish whether combined training outperforms the other interventions.

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.

Dong'e County People's Hospital in eastern China's Shandong province performed a brain-computer interface implant on September 15, 2026, the country's first such procedure at a county-level hospital. The approved system records and decodes brain signals through an epidural implant to control assistive devices. The hospital had previously combined neurology and neurosurgery into a neuroscience center.

Peking University Third Hospital, a top-tier (Grade 3A) general hospital in Beijing whose neurosurgery department is one of its key specialties, is taking part in a clinical trial of a Chinese-developed invasive brain-computer interface (BCI), neurosurgeons Yang Jun and Yu Tao wrote in the 16th issue of China Hospital CEO magazine. The trial enrolls patients with spinal cord injury and relies on a multidisciplinary team (MDT) to restore hand function after implantation. Invasive BCIs read neural signals through electrodes placed inside the skull or on the cortical surface, so surgery and rehabilitation depend on close coordination among neurosurgery, rehabilitation and imaging departments. The disclosure marks one step in Chinese hospitals' clinical validation of domestic systems. Public information has not named the system or disclosed enrollment, follow-up milestones or primary endpoints, and no efficacy or safety data have been released.

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.

Chronic stroke patients who used an at-home brain-computer interface (BCI) therapy system gained a mean 6.0 points on the Upper Extremity Fugl-Meyer Assessment after 12 weeks, versus 1.5 points for those on a home exercise program. Response rates were 55.5% and 9.6%, for a number needed to treat of 2.2. The trial also exposed the dropout problem in home-based studies: 17 of 42 control participants withdrew because they were dissatisfied with their group assignment.

A study registered by the Affiliated Hospital of Shandong University of Traditional Chinese Medicine in eastern China asks whether adding closed-loop BCI exoskeleton training to conventional rehabilitation improves lower-limb recovery after stroke. The retrospective cohort plans to include 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 study is self-funded by the team and has not yet begun recruiting.

About 70% to 80% of stroke survivors cannot live independently because of physical impairment, and regaining the ability to walk is central to changing that. A study registered by the First Affiliated Hospital of the University of Science and Technology of China, in Hefei in eastern China, plans to enroll 200 stroke patients and 200 healthy controls, recording 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 assessment. The goal is a non-invasive BCI dataset for stroke rehabilitation research. The cross-sectional observational study involves no intervention, and first enrollment is set for October 1, 2026.

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.

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.

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.

A Stanford program is recording brain activity in psychiatric inpatients at millisecond precision, combining noninvasive electrode arrays with deep brain recording electrodes to trace the circuits behind schizoaffective disorder, borderline personality disorder, autism and cancer-induced depression. The Human Neural Circuitry program, led by neuroscientist Karl Deisseroth at the Wu Tsai Neurosciences Institute, has run for three years and moves data over fiber-optic and copper links fast enough for round trips of under half a millisecond, allowing the system to sense and respond in a closed loop. Deisseroth said the key innovation is getting results at millisecond precision, which he called a crucial step toward understanding complex psychiatric symptoms.

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.

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, in Wuhan, central China, is sponsoring a multicenter cohort study that aims to enroll 1,000 stroke patients. The treatment arm receives closed-loop rehabilitation combining a brain-computer interface with functional electrical stimulation, and the control arm receives conventional training; the primary endpoint is change in upper- and lower-limb FMA scores two weeks after enrollment. Registered with the Chinese Clinical Trial Registry as ChiCTR2600130037 on August 13, 2026, the study plans first enrollment on September 1, 2026 and has not yet begun recruiting. It will include patients aged 18 to 80 with ischemic or hemorrhagic stroke confirmed by MRI or CT, motor impairment of one upper and/or lower limb, and an NIHSS motor score of 1 for the affected limb. The registry lists it as an observational cohort study, phase 4, self-funded.

A completed RCT compared BCI-controlled versus conventional exoskeleton gait training in stroke patients, training 2 times a week for 4 weeks.

People's Daily Online reported that multiple people with high-level paralysis used StairMed's minimally invasive implantable BCI for three to four consecutive hours of computer work, including e-commerce logistics coordination and vending-machine data labeling. The company reported a 256-channel system and latency below 50 milliseconds. The article did not provide a participant count, standardized protocol or adverse-event table.

A study of 60 patients with subacute stroke hemiplegia found that adding motor imagery brain-computer interface training to conventional rehabilitation significantly improved upper limb motor function, simplified upper limb function scores, and daily living abilities. The experimental group of 30 received 3 weeks of additional BCI training, 5 days per week, while the control group received only conventional rehabilitation. The experimental group showed greater improvements in Fugl-Meyer upper limb scores, simplified upper limb function scores, and Barthel Index, with statistically significant differences.

Zhejiang Provincial People's Hospital performed China's first 320-resolution visual BCI implant; a woman blind for nearly 20 years reportedly reads, writes and walks again.

Surgeons in eastern China have implanted a brain-computer interface in a man who has been unable to move his limbs for more than two years. Eight ultraflexible electrodes sit 4 mm into his cortex, wired to a chip mounted on the skull. It is the first invasive BCI operation performed in Shandong province, and the patient now begins up to six months of training to control devices by thought.

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.