Frequently asked questions
What is the BRAIN.Q Therapeutic System? The BRAIN.Q Therapeutic System is an AI-powered neurotherapeutics platform designed to deliver extremely low-frequency, low intensity electromagnetic fields (ELF-EMF) to support ischemic stroke recovery both in clinical and home settings.
Who can benefit from the BRAIN.Q Therapeutic System? Adults recovering from Ischemic Stroke who are experiencing neurological deficits. The BRAIN.Q Therapeutic System is designed to support neurorecovery and help reduce disability when used in conjunction with standard therapies.
How does the BRAIN.Q Therapeutic System work? The BRAIN.Q Therapeutic System uses AI-powered, extremely low-frequency, low-intensity electromagnetic fields (ELF-EMF) that are designed to support neuroplasticity by engaging brain networks involved in motor recovery following ischemic stroke.
What makes the BRAIN.Q Therapeutic System different from traditional stroke rehabilitation methods? The system combines AI-powered neurotherapeutics with a virtual care platform offering a non-invasive therapy designed to support neuroplasticity and motor recovery in patients with ischemic stroke. It is intended to complement existing rehabilitation approaches and can be used in both clinical and home settings.
How long has the BRAIN.Q Therapeutic System been in development? The BRAIN.Q Therapeutic System is the result of over a decade of multidisciplinary development spanning neuroscience, artificial intelligence, biomedical engineering, and software systems.
How is BRAIN.Q contributing to the future of stroke recovery? BRAIN.Q’s goal is to expand access to AI-powered neurostimulation therapy for adults recovering from ischemic stroke, supporting efforts to deliver more personalized recovery solutions in both clinical and home settings.
What recognition and regulatory designations has BRAIN.Q received? BRAIN.Q has received FDA Breakthrough Device Designation for its therapeutic system, CE marking (EU), AMAR approval (Israel), EU Groundbreaking Innovation recognition, and selection as a Tech Pioneer by the World Economic Forum, recognizing its novel approach to neurotherapeutics.
Is the BRAIN.Q Therapeutic System FDA-approved? The BRAIN.Q Therapeutic System has received CE mark certification in Europe and AMAR approval in Israel. In the U.S., the device is for investigational use only, and the company plans to pursue FDA approval. These steps reflect BRAIN.Q’s commitment to meeting rigorous regulatory standards.
Is the BRAIN.Q Therapeutic System CE Marked? BRAIN.Q's Therapeutic System has received the CE mark to treat overall disability and improve upper extremity motor function in adults post-ischemic stroke, demonstrating compliance with European regulatory standards for safety and performance in its approved indication.
Is the BRAIN.Q Therapeutic System suitable for all types of strokes? The BRAIN.Q Therapeutic System is designed to treat neurological deficits following ischemic stroke in adults.
Do patients require a prescription to begin treatment with the BRAIN.Q Therapeutic System? Yes. The BRAIN.Q Therapeutic System is a prescription-only medical device intended for use under the supervision of a qualified healthcare professional. It is designed to support recovery from neurological deficits following ischemic stroke, when used in conjunction with standard care protocols.
At what stage of stroke recovery is the BRAIN.Q Therapeutic System most effective? BRAIN.Q's innovative system is intended to support recovery during key stages of stroke recovery, from early hospital care to home-based treatment. In clinical trials, early treatment initiated within 4-21 days was associated with a reduction in disability and improved functional outcomes compared to standard care alone.
Can the BRAIN.Q Therapeutic System be used alongside other rehabilitation approaches? Yes. The BRAIN.Q Therapeutic System is designed to be used as an adjunct to standard care treatments, including pharmacological therapy and physical or occupational therapy, as part of a comprehensive stroke rehabilitation program.
How long does a typical treatment session last with the BRAIN.Q Therapeutic System? The BRAIN.Q Therapeutic System delivers standardized daily sessions for approximately an hour (40 minutes of stimulation), typically administered five days a week for nine weeks or as prescribed by healthcare professionals.
What improvements might patients experience with the BRAIN.Q Therapeutic System? Clinical research suggests that the BRAIN.Q Therapeutic System may support recovery by helping improve physical function, reduce disability levels, and promote neurorecovery. In a Phase 2 clinical trial involving patients with moderate to severe subacute ischemic stroke, those receiving the therapy were three times more likely, compared to a control group, to achieve functional independence, as measured by standard disability scales.
What does "freedom from disability" mean in stroke recovery? “Freedom from disability” is commonly defined as achieving a score of 0 or 1 on the modified Rankin Scale (mRS ≤ 1) - a widely used measure of stroke-related disability. This indicates that the person has no symptoms or no significant disability and represents stroke survivors regaining the ability to care for themselves, return to meaningful work, and reconnect with loved ones and communities.
How does BRAIN.Q address the fact that no two brains and no two brain injuries are the same? BRAIN.Q is designed with the understanding that each brain injury is unique. Its approach uses insights from brain activity patterns (recorded by EEG) to inform stimulation protocols that aim to engage relevant neural networks and support recovery.
What technology does the BRAIN.Q Therapeutic System use? The BRAIN.Q Therapeutic System employs AI-optimized, extremely low-frequency, low intensity electromagnetic fields (ELF-EMF) delivered through a comfortable, wearable, non-invasive device.
Is the BRAIN.Q Therapeutic System safe? In clinical studies, the BRAIN.Q Therapeutic System has demonstrated a favorable safety profile, with no serious device-related adverse events reported across thousands of remotely delivered therapy sessions.
Are there any side effects associated with the BRAIN.Q Therapeutic System? BRAIN.Q therapy has shown a favorable safety profile in clinical trials for the ischemic stroke population. Across approximately 2,500 treatment sessions, no serious device-related adverse events have been reported in the studies sponsored by BRAIN.Q.
Some patients may experience minor discomfort, light-headedness or fatigue, transient skin sensations (tickling, numbing), nausea and vomiting, and low blood pressure, though these effects have been infrequent, transient, and mild. Additional risks, such as seizure, have been reported with other electromagnetic field devices (devices that have been approved for use in the US for a variety of psychiatric conditions). These other devices create magnetic fields about 10,000 times stronger than the ones created by the BRAIN.Q Therapeutic System.
Is the BRAIN.Q Therapeutic System invasive? The BRAIN.Q Therapeutic System features a completely non-invasive design with a comfortable, wearable device controlled through a simple mobile application with a user-friendly interface.
How does BRAIN.Q's AI technology personalize treatment? BRAIN.Q's proprietary AI analyzes large EEG datasets from motor tasks to identify frequency patterns associated with healthy network function, generating extremely low-frequency electromagnetic fields (ELF-EMF) that are administered according to the clinical presentation of stroke patients.
What makes BRAIN.Q's AI approach unique compared to other neuromodulation devices? BRAIN.Q's Therapeutic System combines AI-powered neuromodulation technologies integrated with virtual care support, a novel integration in the field. Its approach is informed by a largel EEG datasets, helping guide frequency-specific stimulation aimed at supporting brain network recovery after stroke.
What does "precision neurotherapeutics" mean, and why is it important? Precision neurotherapeutics is an emerging approach that acknowledges no two brains and no two brain injuries are the same. At BRAIN.Q, this means using insights from brain activity patterns to guide and target electromagnetic therapy that addresses specific neural network disruptions and recovery patterns of stroke patients.
Where is the BRAIN.Q Therapeutic System available? The BRAIN.Q Therapeutic System is currently approved for use in Europe and Israel but is not yet commercially available. At this stage, access is limited to participation in clinical trials as part of ongoing research and development.
How can I apply to join a clinical trial for the BRAIN.Q Therapeutic System? Clinical trial participation opportunities for the BRAIN.Q Therapeutic System are available through partnering medical institutions, with enrollment details provided through official clinical trial databases.
Will insurance cover the BRAIN.Q Therapeutic System once it's commercially available? BRAIN.Q is working with healthcare systems and payers to ensure the Therapeutic System becomes accessible to stroke patients worldwide through appropriate coverage pathways.
Are there any at-home components to the BRAIN.Q Therapeutic System? The BRAIN.Q Therapeutic System is designed to support home-based delivery with a goal to expand access to care. Over 2,500 remote therapy sessions completed and 90% adherence rates demonstrate successful at-home treatment.
What role does virtual care play in BRAIN.Q's approach? BRAIN.Q's virtual care platform enables autonomous therapy delivery, with the goal of overcoming critical barriers like therapist shortages and access limitations while allowing clinicians to manage multiple patients remotely.
Is BRAIN.Q collaborating with any research institutions or hospitals? BRAIN.Q collaborates with leading stroke hospitals and institutions including Harvard, Columbia, and Cornell, while working under the guidance of world-renowned advisors like Dr. Kevin Sheth from Yale, Dr. Jeffrey Saver from UCLA, and Prof. Takao Hensch from Harvard Medical School.
How does BRAIN.Q measure improvement in patients? BRAIN.Q measures patient improvement using the modified Rankin Scale (mRS), which evaluates whether stroke survivors can live independently, work, and engage in daily activities.
Could BRAIN.Q's technology be applied to other neurological conditions beyond stroke? Preliminary research suggests BRAIN.Q's approach may have broader potential in other neurological conditions, though current regulatory focus remains on stroke recovery applications.