Abbreviation: rTMS, repetitive transcranial magnetic stimulation. If you would like to get started, you can find our contactÂ informationÂ here. To request the Agency’s review of your protocols, you can submit a pre-submission to the Agency. the location of the test report in the submission. rTMS This is commonly abbreviated to just “TMS” but technically the ‘r’ is added to convey that the stimulation received is repetitive. The measures recommended to mitigate these identified risks are given in this guidance document, as shown in the table below. Electromagnetic compatibility safety requirements for the rTMS device should be clearly stated in the product labeling. We know 60 definitions for RTMS abbreviation or acronym in 7 categories. Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression. This discussion should also describe how you have ensured positioning consistency and repeatability. the ability to place the patient in a safe position for seizure management. It is also unaffected by the type and quality of road pavement • Self-contained RTMS does not require auxiliary equipment (e.g. We recommend you follow the relevant principles discussed in the CDRH guidance document entitled, Guidance on Medical Device Patient Labeling.9 For rTMS systems, we recommend physicians provide patients with the patient labeling that includes the following information. “MT level” is determined with the rTMS treatment coil positioned over a specific location within the motor strip, called the motor threshold location (MT location).10 The MT location may be used as an anatomic reference point for navigating the coil to the rTMS treatment location. R epetitive transcranial magnetic stimulation (rTMS) ... Auditory thresholds and performance on the following ... and the stand-walk test were assessed on days 2 and 3 of treatment. Failure to follow this restriction could result in serious injury or death. RTMS definition / … Labeling should describe how to determine the rTMS treatment location in sufficient detail for the user to understand how to identify, transition to, and record any coordinates needed for reproducible positioning from session to session. Before sharing sensitive information, make sure you're on a federal government site. comorbid psychiatric and neurological disorders. Labeling recommendations in this guidance are consistent with the requirements of Part 801. Sponsors must conduct clinical studies in compliance with 21 CFR parts 50, 56, and 812. “Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5–7, 1996,” Electroencephalography and clinical Neurophysiology 108 (1998) 1–16. The scope of this document is limited to the repetitive transcranial magnetic stimulation (rTMS) system, (21 CFR 882.5805 and product code OBP) described below. You should specify the number and frequency of treatments and overall duration of treatment exposure. This includes patients with pacemakers and implantable cardioverter defibrillators (ICDs), as well as patients using wearable cardioverter defibrillators (WCDs), even if the device is removed, due to the potentially unstable cardiac condition of such patients. Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Transcranial magnetic stimulation (TMS), including repetitive transcranial magnetic stimulation (rTMS) and deep transcranial magnetic stimulation (dTMS), is a noninvasive method of delivering electrical stimulation to the brain. In cases where clinical testing is needed, FDA recommends that the clinical study be designed to demonstrate the substantial equivalence of safety and effectiveness of your device when used as described in the Indications for Use statement. If the physical characteristics (including differences in spatial and temporal characteristics) of your device’s magnetic field differ from the predicate’s magnetic field, you should provide valid scientific evidence that these different technical characteristics do not affect the safety or effectiveness of your device, as compared to the predicate device. You should also describe features and quality measures included in your system to ensure proper system output for each treatment and from unit-to-unit. The warning section of the labeling should include a table that lists all devices that are known to be adversely affected by the rTMS device. You should describe an a priori method of randomization and provide a method to ensure integrity of the study blind in detail. RTMS also stands for: Rail Transportation Management Services; Rail Transportation Management Specialists; Really Tight Male Sphincter; Remote Traffic Microwave Sensor; Rental Tool Management System... and 6 more » Nearby & related abbreviations: RTMF; RTMI; RTMM; RTMNU; RTMP; RTMSD; RTMT; RTMX; RTMZ; RTN; Alternative search: Search Real Time Monitoring System on Amazon Clinical Information. What does RTMS stand for? Submit electronic comments to http://www.regulations.gov. dorsolateral prefrontal cortex), and the specific technical parameters for stimulation. Labeling should include a precaution that describes the limitations of available information on the safety and effectiveness of long term treatment with the rTMS device. cardiac pacemakers, cardioverter defibrillators, or neurostimulators. We recommend that you submit the information for software-controlled devices described in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (the Software Guidance).5 The kind of information we recommend you submit is determined by the “level of concern,” which is related to the risks associated with software failure. We recommend that you assess the adequacy of blinding, by asking patients to guess their treatment group and the reason for their guess. Results: After stimulation, the grip strength increased in the SAS and rTMS group compared to the control and combined group. Device effectiveness: You should specify the primary and secondary effectiveness endpoints for the study. Patients and those operating the device should always wear earplugs or similar hearing protection devices with a rating of 30dB of noise reduction during rTMS treatment. Looking for the definition of RTMS? rTMS stands for “repetitive transcranial magnetic stimulation.” This is commonly abbreviated to just “TMS” but technically the ‘r’ is added to convey that the stimulation received is repetitive. You should specify your null and alternative hypotheses. Labeling should also cite relevant guidelines (e.g., 1998 National Institute of Neurological Disorders and Stroke (NINDS) Workshop) for rTMS stimulation parameters 3 which are also summarized in Section 4. Different types of therapy for depression. You should also determine the severity and duration of each adverse event. The FDA approved treatment protocol for rTMS is the following: Intensity: 120% of motor threshold Describe the potential benefits of your device and probability of such benefits based upon your clinical trial. You should perform testing for electromagnetic compatibility for all device output modes. Patient labeling for rTMS systems should state the following: Based upon the information from your clinical trial, describe the patient population for the device. Your device description should also include: In addition, you should include the following information describing your device. The device is intended to be used to treat patients meetin… The consensus concerning the limits of safe rTMS in terms of the risks of seizure induction (Wassermann, 19983) is cited in Section 4. Weaknesses of RTMS? We recommend you provide the dimensions of the treatment target stimulation volume and its location relative to the applicator. The time rate of change of B determines the current density level induced in the cortex; therefore, dB/dt is used to express the strength of the field induced by the magnetic field at a given point. These requirements should indicate whether the device’s proximity to the treatment coil is contraindicated, should be kept at a safe distance from the magnetic coil, or should be removed from the patient area. The list of abbreviations related to RTMS - Read the manual, stupid The Shepherd Center Study Group used the Quality of Disability Research Instruments (Farkas, Rogers, & Anthony, 2008) to rate the rigor and … We recommend that you collect targeted safety outcomes for auditory threshold, such as pre- and post- audiograms, and cognitive function. The labeling should include a warning regarding the possible effects of the rTMS device when used in patients who have implanted devices that are activated or controlled in any way by physiologic signals, irrespective of the distance from the treatment coil. at 301-796-6493 or by email at firstname.lastname@example.org. 10 Rothwell JC, Hallett M, Berardelli A, Eisen A, Rossini P, Paulus W, Magnetic stimulation: motor evoked potentials. You should identify all salient features of the waveform (e.g., pulse width) and specify the horizontal and vertical oscilloscope gain settings. the primary efficacy endpoint which should be based on a validated assessment tool; the secondary efficacy endpoints which should also be based on validated assessment tools and should assess any benefits for which you plan to claim effectiveness; and. A course of rTMS traditionally requires multiple treatments. We also recommend you apply an appropriate randomization blocking procedure to balance the number of subjects in each participating center between control and treatment groups in order to facilitate an assessment of the poolability of data across centers. Train duration: 4 seconds (how long the stimulation is administered) at 10 pulses a second for a total of 40 pulses Example of a Device and Predicate Comparison. The limits depend upon the amplitude of stimulation, pulse frequency, and duration of the pulse train. Introduction. We recommend you describe the physical characteristics of the magnetic field produced by your device and compare them to those of the predicate device. If such an interaction term is found to be statistically significant, your statistical summary should include a discussion of the implication of the statistically significant interaction on the overall interpretation of the study results. 6 We recommend that you request the Agency’s review of your protocols prior to initiating clinical studies for your device. We recommend both treatment and control groups be studied at the same site(s). You should also describe the method used to ensure that the coil is in proper position and contact with the patient’s head during MT and rTMS treatment procedures. 120% MT. FDA also recommends that the adequacy of blinding be assessed. It should also cover the design features of the rTMS device, methods for training in the use of the device and appropriate methods to describe the safety and risks of the device in the treatment of patients with major depression. 9http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070782.htm. rapid removal of the coil from the patient; and. The pulsed rTMS magnetic field has the potential of interacting with pacemakers and other active implanted devices, potentially causing their malfunction and subsequent patient injury. We recommend you conduct biocompatibility testing on any patient contacting materials used in your device as described in the FDA guidance, Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing4 for external devices in contact with the skin for a limited duration (i.e., less than 24 hours). TMS is typically used when other depression treatments haven't been effective.This treatment for depression involves delivering repetitive magnetic pulses, so it's called repetitive TMS or rTMS. The determination of MT level and treatment location is typically not repeated at every session. Repetitive Transcranial Magnetic Stimulation; River Trails Middle School (Mt Prospect, IL) Ruan Transportation Management Systems (Des Moines, IA) Ruth Thompson Middle School (Mississauga, ON, Canada) Real-Time Monitoring Tool; Remote Transmitter; Raritan Township Municipal Utilities Authority (Flemington, NJ; sewer service) RTMS high accuracy performance is not affected by precipitation of any kind, vibration and lighting conditions. When applying rTMS, a coil is put at a precise and particular location on the head. Your statistical hypothesis should describe the specific statistical model proposed for the main analysis and any relevant secondary analyses. We recommend you identify your device using the regulation and product code described in Section 2. Frequency: 10 Hz You should also include a description of the method used for these measurements and how they have been validated. 3 The recommended maximum train duration (in seconds) for healthy adults for the intensity (% of Motor Threshold) levels and frequencies are shown in Table 2. In addition, we recommend that you provide a calibration curve between the settings on your device and measure the magnetic field strength at an appropriate standard location and compare this to the predicate device. The units for magnetic field flux (i.e., dB/dt) are Tesla/second. We recommend you include the following: You should select biocompatibility tests appropriate for the duration and nature of contact with your device. Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes. You should indicate whether your device falls within the limits listed in Table 2. 8 Although final labeling is not required for 510(k) clearance, final labeling must comply with the requirements of 21 CFR Part 801 before a medical device is introduced into interstate commerce. Table 1. We recommend that you demonstrate the electrical and mechanical safety of the device by performing electrical and mechanical safety testing as described in the FDA-recognized standard, IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety or by an equivalent method. The warning should describe the appropriate distance between the rTMS device and other devices, so the magnetic field does not cause movement, heating, or dysfunction of these other devices. See Appendix A for discussion of terms used in Table 2. Treatment by site interactions: Multicenter studies should include a measure to assess any significant treatment by center interaction on the primary effectiveness measure. This includes imputation methods, such as multiple imputation, and sensitivity analyses, such as imputing various proportions of missing outcomes (of a binary endpoint) as “successes” or “failures.”. rTMS stands for repetitive Transcranial Magnetic Stimulation or brain stimulation in short. Moreover, the setting for your device should be traceable to a reproducible physical parameter (see Magnetic Field Characteristics, below). The firm will need to show that its device addresses the issues of safety and effectiveness identified in this guidance, either by meeting the recommendations of this guidance or by some other means that provide equivalent assurances of safety and effectiveness. For example, for a treatment at the 120% MT level, the field at the boundary of the stimulation volume is equivalent to the MT level and all tissue within the stimulation volume is above the MT level. Center for Devices and Radiological Health, Office of Device Evaluation Recommendations for a clinical study are provided below.6. baseline depression severity, based on validated depression scale. You should describe the method used by your device to recall treatment history, such as prior patient treatment settings. Physician labeling should include patient labeling with instructions to the physician to provide such labeling to the patient. For clinical studies of rTMS devices, device safety data should include the incidence of serious adverse events, e.g., worsening depression, suicidal ideation, suicide attempt, suicide, switching to hypomania/mania, seizure, death, and device malfunction resulting in patient or operator injury. In addition, the warnings should summarize the compatibility requirements for each device and electrically conductive object in the vicinity of the rTMS device treatment coil. the standardized effect size for continuous outcome measures and/or the number-needed-to-treat (NNT) for categorical endpoints. The training should ensure operator competency and uniform, optimal treatment technique to safely and effectively use the device for the purposes described in the indication. The total duration of the treatment is 18 min 26 seconds with a total of 3000 pulses. You should discuss the design features that are used for positioning the coil and patient for rTMS treatment. In addition, you should address other subject characteristics, including: Treatment parameters: Treatment parameters should be standardized and should be specified in detail in your protocol. Gait and Sequential Hand and Arm Movement Time (mean ± standard error) at Baseline, a 1 Day, and 1 Month After the Last 50-Hz rTMS and Sham Intervention FDA believes that the software used to operate a rTMS device presents a “moderate level of concern” as described in the Software Guidance because a failure or latent design flaw could either directly result in minor injury to the patient or operator or could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. The following study design features should be stated clearly in the study protocol document. Validated depression assessment scales should be used as the primary endpoint. In addition, final labeling for prescription medical devices must comply with 21 CFR 801.109. We also recommend that you describe how any differences between your device and the predicate device may affect the comparative safety and effectiveness of your device. Number or trains per sessions: 75 trains. 4http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm, 5http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm. Electromagnetic Compatibility also should be provided. The labeling should instruct the prescribing physician to screen each patient for the presence of these devices. The single pulse machine was first described by Barker et al. For monophasic pulse shapes, we recommend reporting pulse width as the time between the rising phase and falling phase of the wave measured at a standard amplitude (e.g., 10% of total amplitude). Please use the document number 1728 to identify the guidance you are requsting. Following their second course of rTMS, they received clustered maintenance rTMS which involved monthly maintenance sessions of five rTMS treatments over a two day period. Contraindicated use could result in serious injury or death. You should describe any safety features included to address the risk of seizure. In the table below, FDA has identified the risks to health generally associated with the use of the rTMS system addressed in this document. In addition to graphical representations, a tabular format that summarizes the output specifications is desirable. If medications are ineffective, therapy can utilized to help with depression (CBT – cognitive behavioral therapy, IPT – interpersonal therapy, psychodynamic therapy, behavioral activation). Dose and duration of antidepressant trials should be documented using an antidepressant treatment history form (ATHF). Diabetes mellitus is a clinical syndrome characterized by hyperglycemia caused by respective or absolute deficiency of insulin. You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers lane, rm. The site is secure. Scope, and provide a complete description of your rTMS system. The labeling should also contain a description of the clinical trial population that identifies the study population according to treatment severity and duration of disease. In addition, FDA recommends that you assess a patient reported outcome such as quality of life as one of your secondary endpoints. You must provide information to show how the new device is similar to and different from the legally marketed predicate device ("predicate device") (21 CFR 807.87(f)). Note that the paper by Wassermann 3 and this guidance document address safe limits for the use of rTMS when used as a stand alone therapy. The nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB) was the key up-regulated protein in the SAS group while src homologus and collagene gene (SHC) and p90 ribosomal protein S6 kinases (p90RSK) were key up-regulated proteins in the rTMS group. TMS (Transcranial magnetic stimulation) therapy uses short pulses of magnetic fields to stimulate nerve cells in the area of the brain thought to control mood. The inability to detect component failure or drift may affect the safety or effectiveness of rTMS treatment. For non-inferiority studies with an active control, you should base the determination of effectiveness on the intent-to-treat populations. Strengths of RTMS? The pick-up loop for making this measurement should be located at the same distance from the coil as the target tissue in the brain. FDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of rTMS systems for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. Magnetic field strength is determined by measuring the voltage induced across a small pickup loop placed at the location of interest. If you would like to learn more about TMS in general, you can continue to read on our site. Indication for use: The indication for use should identify the patient population for whom the device is indicated, including the DSM-IV diagnosis, treatment severity, and medication resistance. Due to safety concerns, we recommend you exclude subjects who have any metal implanted in the head (except the mouth), e.g., subjects with cochlear implants, implanted brain stimulators, ocular implants, aneurysm clips or stents. the test (e.g., electrical characterization, electromagnetic compatibility (EMC)); the mode of device operation during the test; the standard to which conformance was demonstrated; and. The following suggestions are aimed at assisting you in preparing labeling that satisfies the applicable requirements of 21 CFR Part 801.8 For the rTMS system, such labeling includes patient labeling (described below) with instructions to the physician to provide the patient labeling to the patient so that the practitioner who is licensed by law to administer the device can use the device safely and for the purpose for which it is intended (21 CFR 801.109(c)). If the spatial distribution differs from that of the predicate device, you should explain how your device is as safe and as effective as the predicate device despite the difference. The labeling should include a warning that wearable/removable medical devices, other devices or conductive objects (including personal items) that may be affected by the magnetic field should be removed from the patient area before treatment to prevent possible injury to the wearer or damage to the device. rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil. Software Life Cycle and risk Management should also be provided. You should also collect incidence of common adverse events such as headache, application site pain, and discontinuation rate due to adverse events.