Brain Ultimate TMS Therapy

Safety Features

Certification

Brain Ultimate TMS M-Series by Yingchi Technology sets a new industry standard in Transcranial Magnetic Stimulation (TMS) with its superior precision, efficiency, and dependability, outperforming existing market offerings. It stands out as the first TMS system to achieve China's NMPA/CFDA Class III certification, further solidifying its leadership position through global recognitions such as FDA clearance, EU CE Marking, Australia's TGA, South Korea's KFDA and so on. This underscores its adherence to the highest international quality and safety standards.

Overheating Protection

The Brain Ultimate/Yingchi Technology TMS system, which consists of a stimulator, cooling unit, and coil, has superior thermal regulation and several temperature sensors that continuously monitor conditions in real time. When temperatures rise above 105.8°F (41°C), a key safety feature known as the "automatic system shutdown" is activated, thereby preventing overheating. This system actively monitors liquid levels, temperature, and operating status to ensure maximum safety and functionality.

LED Indicator for Operating Status

The Brain Ultimate/Yingchi Technology TMS liquid cooling unit ensures consistent and efficient coil cooling, resulting in optimal performance and safety during operation. It meticulously monitors liquid temperature, volume, and circulation to ensure that all conditions are appropriate. Furthermore, the device has an LED indication that provides real-time data on liquid temperature, volume, and circulation status, enabling for quick operational adjustments and oversight.

Pulse Counter

To ensure optimal dosage delivery and maintain coil integrity, Brain Ultimate/Yingchi Technology TMS Coils are designed for a lifespan of 20,000,000 pulses, as specified by the manufacturer. Each coil is equipped with an intelligent pulse counter that accurately tracks the number of pulses delivered, allowing precise monitoring of coil usage.

Patient Data Security and Secure Operational Access

Brain Ultimate/Yingchi Technology TMS system is configured to operate exclusively with an authorized dongle issued to the attending physician. This protocol enhances the security of patient data, preserves confidentiality, protects programmed settings, and restricts operational access to authorized personnel only.

Navigating TMS Treatment: A Step-by-Step Guide

  1. Measuring Motor Threshold (MT):
    1. Open the QUICKSTIM Software and either create a new patient profile or select an existing one from the patient list.
    2. Properly fit the TMS positioning cap on the patient, ensuring their palms face upward and they are fully relaxed.
    3. Determine the patient’s accurate MT value using either the OM-MT (Observational Muscle Twitch) or EMG-MT (Electromyography Muscle Twitch) method.
  2. Protocol Selection or Configuration:
    Choose the prescribed protocol from the list of saved protocols, or create a new one as prescribed by the physician. Enter the specified parameters (Frequency, Intensity, ISI, ITI, Number of Pulses, Number of Trains) and save the new protocol.
  3. TMS Treatment Setup:
    1. Identify the designated stimulation target.
    2. Position the TMS treatment coil directly over the marked target.
    3. Ensure the patient is comfortable and inform them that the session will begin shortly.
  4. Operational Steps for TMS Treatment:
    1. Continuously observe the patient during the treatment.
    2. Check in with the patient to assess their comfort and collect feedback.
    3. Verify the details of the patient’s next scheduled appointment.
    4. If needed, print or export the treatment report.

TMS Treatment Process

Precision of Target Positioning. There are three commonly used methods for locating therapeutic target.

5cm rule: After finding the RMT hotspot, move forward 5cm to find the DLPFC treatment target.

Positioning Cap: Using YINGCHI positioning cap which is designed based on the EEG 10-20 electrode placement system to select the closest electrode position. For example, the left DLPFC can choose F3 electrode position as the target. Positioning caps are available in different sizes, suitable for patients of different ages.

TMS 3D Navigation System: MRI based neuronavigator provides a professional solution for the precise positioning of MRI based neuronavigator realized rTMS target personalization (based on individual brain structure, function or functional connection between brain areas), reproducibility and visualization.

Patient Motor Threshold (MT)

What is MT? MT is the minimum amount of electrical energy a patient needs for TMS to elicit motor movement. MT measure is conducted with the patient in a "resting state" and is sometimes called resting motor threshold (RMT). MT or RMT can be understood as "TMS dose".

Why determining MT is required before TMS treatment? MT is recognized as the "gold standard" for determining TMS dose. Delivering TMS treatment at the correct dose guards patient safety against the possibility of inadvertent seizure, its relationship to efficacy and reproducibility in cortex stimulation. Resting Motor Threshold (RMT or MT) is determined by using visual observation of muscle twitch (OM-MT) or electromyography muscle twitch (EMG-MT).

TMS Coils

Advantages of Innovative Coil Technology

  • The cooling system is exceptionally effective and efficient, safeguarding against overheating and ensuring optimal performance during extended use.
  • The coil's lightweight design facilitates robust power delivery without compromising usability
  • The coil handle is equipped with adjustable intensity controls and an LED display, simplifying the process of setting the intensity during Motor Threshold (MT) measurements.
  • The coil features a 20,000,000 pulse counter with an LED display on the handle, allowing for precise tracking of usage.

Recommended Clinical TMS Coils

Liquid Cooled Double Cone Coil

The Figure 8 Coil, featuring Liquid Cooling and an Angulated design, is at the cutting edge of TMS coil technology. Designed specifically for the Brain Ultimate TMS systems, it incorporates an angulated shape that conforms closely to the contours of the human skull. This unique design enhances the efficiency and precision of brain stimulation, making it especially effective for targeting deeper brain areas. Its advanced liquid cooling system regulates the coil's temperature, facilitating continuous use without the risk of overheating. This feature not only improves the safety and longevity of the coil but also solidifies its value for FDA-cleared treatments.

Liquid Cooled Flat Figure 8 Coil

The Figure 8 Coil featuring Liquid Cooling and a Flat design is a key component of the Brain Ultimate TMS system. Engineered for deep and precise brain stimulation, this coil's flat design ensures a more comfortable fit and effective application across different head shapes. Its advanced liquid cooling technology maintains consistent performance throughout extended treatments by efficiently managing heat. This not only prolongs the coil’s lifespan but also enhances patient safety.

The video compilation presented by Yingchi Technology and listed on this page serves as an educational resource. It's crucial to acknowledge that this compilation does not make any claims to diagnose, treat, or cure any health conditions, adhering to US FDA guidelines. The purpose of this content is to highlight research findings utilizing this method in various fields, showcasing its potential shift from diagnostic practices to therapeutic interventions. Viewers should critically evaluate the material with an awareness of its limitations, except in cases where the application has been granted FDA clearance.

Precision in Therapeutic Target Positioning

Three common methods are utilized to precisely locate therapeutic targets.

The "5 cm rule" is a method traditionally used to locate the dorsolateral prefrontal cortex (DLPFC) for transcranial magnetic stimulation (TMS) targeting. It involves measuring 5 cm anteriorly in a parasagittal line from the motor cortex, typically identified when stimulation induces thumb movement. However, the FDA advises caution using this rule due to individual variations in brain anatomy which can affect the accuracy of the DLPFC targeting. This could potentially impact the effectiveness and safety of the treatment.

Publications such as George et al. (1996), which helped establish this rule, and Herwig et al. (2001), which discussed its anatomical accuracy, justify the need for careful application. Both studies highlight the variability in brain anatomy among individuals, suggesting that while the 5 cm rule is a useful starting point, precise targeting should be confirmed with neuroimaging techniques to ensure the safety and efficacy of TMS.

Transcranial Magnetic Stimulation (TMS) positioning caps are used to improve the accuracy and repeatability of coil placement during treatment sessions. These caps often have grid systems or marked coordinates to help practitioners locate and return to specific brain areas across treatments. The FDA highlights the importance of using these devices correctly to ensure effective stimulation and patient safety.

Supporting the use of positioning caps, a publication by Fitzgerald et al. (2009) discusses how these aids can enhance the precision of targeting and reduce variability in treatment outcomes. The study emphasizes that while positioning caps are a valuable tool, their effectiveness largely depends on initial accurate mapping of the stimulation sites through methods like MRI-guided neuronavigation, which can confirm the specific areas of the brain that correspond to the cap’s marked locations. This integration of technologies helps to uphold both the efficacy and safety of TMS procedures.

Neuro-navigation is increasingly used in clinical settings to enhance the precision of Transcranial Magnetic Stimulation (TMS) by accurately targeting specific brain regions based on individual anatomical MRI data. This technology improves the consistency and efficacy of treatments by mapping the TMS coil's position in real-time relative to the patient's brain anatomy.

The FDA cautions that while neuro-navigation can increase the accuracy of TMS, practitioners must ensure that the system is calibrated correctly and that MRI data is up-to-date to avoid discrepancies that could affect treatment outcomes.

Support for the clinical benefits of neuro-navigation is provided in a publication by Sackeim et al. (2020), which demonstrates that neuronavigation-assisted TMS leads to more precise and personalized treatments, potentially increasing therapeutic outcomes in depression therapy. This study underscores the importance of integrating advanced imaging technologies in TMS to maintain high standards of care.

Motor Threshold in TMS: Balancing Safety with Treatment Effectiveness

Motor Threshold (MT), often referred to as the Resting Motor Threshold (RMT) in clinical settings, is considered the "gold standard" for determining the appropriate dose of Transcranial Magnetic Stimulation (TMS). Correct dosing is crucial not only for ensuring the safety of the patient—specifically by preventing the risk of inadvertent seizures—but also for maintaining the efficacy and reproducibility of cortical stimulation. The FDA underscores the importance of accurate MT assessment to mitigate the risk of overstimulation, which can lead to serious adverse effects including seizures.

MT is typically determined by one of two methods: visual observation of muscle twitch (OM-MT) or electromyography muscle twitch (EMG-MT). OM-MT involves direct observation of a physical response (such as a thumb twitch), while EMG-MT uses electromyography to record electrical activity in response to neural stimulation.

Support for the pivotal role of MT in TMS protocols is provided in publications like Pascual-Leone et al. (1996), which discusses the methodological considerations for TMS and stresses the importance of MT measurement in optimizing treatment safety and effectiveness. Another key reference is Rossi et al. (2009), which details the safety guidelines for TMS and further substantiates the need for precise MT determination to ensure consistent and safe treatment outcomes. These studies highlight the critical nature of MT in the administration of effective and safe TMS therapy.

User-Friendly TMS QUICKSTIM Software

QUICKSTIM software is internationally recognized and complimented by industry users for its user-friendly design and utility.

Patient’s File Creation and Save Function

To create a new patient file, click "ADD", enter patient details and save. To locate existing patient file, click "SELECT" to access patient list.

New Protocol creation and accessing saved Protocols

Click "ADD"to create a customized or new Protocol. Click "SELECT"to access existing Protocol list.

Example of an FDA Approved TMS Protocol for Depression (MDD) Treatment

MDD TMS treatment session lasted approximately 37.5 min for a total of 3000 pulses, at a repetition rate (Frequency) of 10 pulses/sec (10Hz), with a stimulus train duration (ISI Time) of 4 sec and an inter-train-interval (ITI Time) of 26 sec., on the Left Dorsolateral prefrontal cortex (L-DLPFC).

Create Custom Sequence Protocols

Easily create custom sequence protocols that incrementally increases Intensity. Easily create a multi-protocol sequence by selecting different protocols that are combined and actioned as a single listing.

Generate, Print or Export Reports at a Click

Completed or interrupted treatment sessions are recorded and saved automatically. Treatment reports include patient details, treatment information, protocol details, patient feed-back, clinician notes. Generated reports can be printed or exported in word or PDF format.

Records: Patient TMS Treatment History

Patient TMS treatment record can be exported in “table" format. A referring doctor can remotely track their Patient's treatment history and file records. Treatment history record includes information on all treatment sessions, treatment dates and times, stimulation results, Protocol details, Time and length of each session, Patient session feed-back, Clinician notes and feedback.

TMS unit with Embedded Software

The embedded software enables the stimulation generator to operate independently. The stimulation generator provides 5 shortcut keys on the front panel to set frequently-used protocols.

Effects of intermittent theta-burst transcranial magnetic stimulation on post-traumatic stress disorder symptoms: A randomized controlled trial

Psychiatry Research - 2023.1

The assessment of interhemispheric imbalance using functional near-infrared spectroscopic and transcranial magnetic stimulation for predicting motor outcome after stroke

Frontiers in Neuroscience - 2023.08

The VLPFC-Engaged Voluntary Emotion Regulation:Combined TMS-fMRI Evidence for the Neural Circuit of Cognitive Reappraisal

Journal of Neuroscience - 2023.08

Connectomic insight into unique stroke patient recovery after rTMS treatment

Frontiers in Neurology - 2023.07

The role of ventrolateral prefrontal cortex on voluntary emotion regulation of social pain

Human brain mapping - 2023.06

Effects on resting-state EEG phase-amplitude coupling in insomnia disorder patients following 1 Hz left dorsolateral prefrontal cortex rTMS

Human brain mapping - 2023.06

Motor cortical plasticity as a predictor of treatment response to high frequency repetitive transcranial magnetic stimulation (rTMS) for cognitive function in drug-naive patients with major depressive disorder

Journal of affective disorders - 2023.05

Efficacy of high-frequency repetitive transcranial magnetic stimulation in a family with spinocerebellar ataxia type 3: A case report

Heliyon - 2023.05

Case report: High-frequency repetitive transcranial magnetic stimulation for treatment of hereditary spastic paraplegia type 11

Frontiers in Neurology - 2023.05

Excitatory brain stimulation over the left dorsolateral prefrontal cortex enhances voluntary distraction in depressed patients

Psychological Medicine - 2023.02

The potential of electroencephalography coherence to predict the outcome of repetitive transcranial magnetic stimulation in insomnia disorder

Journal of psychiatric research - 2023.02

Theta-burst stimulation of TMS treatment for anxiety and depression: A fNIRS study

Journal of affective disorders - 2023.01

Default mode network mechanisms of repeated transcranial magnetic stimulation in heroin addiction

Brain imaging and behavior - 2022.11

The causal role of the bilateral ventrolateral prefrontal cortices on emotion regulation of social feedback

Human brain mapping - 2022.07

Repetitive transcranial magnetic stimulation modulates coupling among large-scale brain networks in heroin dependent individuals: A randomized resting-state functional magnetic resonance imaging study

Addiction biology - 2022.03

Effects of Acceptance and Commitment Therapy and Repetitive Transcranial Magnetic Stimulation on Obsessive–Compulsive Disorder

Frontiers in psychiatry - 2022.01

Repetitive Transcranial Magnetic Stimulation (rTMS) Modulates Thyroid Hormones Level and Cognition in the Recovery Stage of Stroke Patients with Cognitive Dysfunction

Medical science monitor : international medical journal of experimental and clinical research - 2021.10

Effect of transcranial magnetic stimulation on treatment effect and immune function

Saudi Journal of Biological Sciences - 2021.09

The VLPFC versus the DLPFC in Downregulating Social Pain Using Reappraisal and Distraction Strategies

The Journal of neuroscience : the official journal of the Society for Neuroscience - 2021.02

The efficacy of repetitive transcranial magnetic stimulation on emotional processing in apathetic patients with Parkinson’s disease: A Placebo-controlled ERP study

Journal of affective disorders - 2020.12

Changes of resting-state EEG microstates induced by low-frequency repetitive transcranial magnetic stimulation

Annual International Conference of the IEEE Engineering in Medicine and Biology Society. - 2020.07

The Lasting Effects of Low-Frequency Repetitive Transcranial Magnetic Stimulation on Resting State EEG in Healthy Subjects

IEEE Transactions On Neural Systems And Rehabilitation Engineering - 2020.04

The right VLPFC and downregulation of social pain: A TMS study

Human brain mapping - 2019.11

"High-Frequency Repetitive Transcranial Magnetic Stimulation Mediates Autophagy Flux in Human Bone Mesenchymal Stromal Cells via NMDA Receptor–Ca2+–Extracellular Signal-Regulated Kinase–Mammalian Target of Rapamycin Signaling"

Frontiers in neuroscience - 2019.11

The lasting effects of 1Hz repetitive transcranial magnetic stimulation on resting state EEG in healthy subjects

Annual International Conference of the IEEE Engineering in Medicine and Biology Society. - 2019.07

Items marked with* are investigational devices and for research use only. CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use.