(176 days)
K193006 MagVenture TMS Therapy
No
The summary does not mention AI or ML, and the device description focuses on electromechanical and software components for delivering magnetic stimulation.
Yes
The device is intended for the "treatment of Major Depressive Disorder" and "Obsessive-Compulsive Disorder (OCD)", indicating a therapeutic purpose.
No
The device is described as a treatment system for Major Depressive Disorder and Obsessive-Compulsive Disorder via transcranial magnetic stimulation, and its purpose is to deliver therapeutic magnetic stimulation, not to diagnose conditions.
No
The device description explicitly states that the Horizon® 3.0 TMS Therapy System is an "integrated system consisting of a combination of hardware, software, and accessories." It also describes it as a "computerized, electromechanical medical device."
Based on the provided text, the Horizon® 3.0 TMS Therapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Horizon® 3.0 Function: The Horizon® 3.0 TMS Therapy System is described as a device that produces and delivers magnetic stimulation to the cerebral cortex to treat Major Depressive Disorder and Obsessive-Compulsive Disorder. It directly interacts with the patient's body and does not analyze samples taken from the body.
Therefore, the Horizon® 3.0 TMS Therapy System falls under the category of therapeutic medical devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Horizon® 3.0 TMS Therapy System is intended to produce and deliver non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex.
Horizon® 3.0 TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Product codes (comma separated list FDA assigned to the subject device)
OBP, QCI
Device Description
The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. ("TMS").
The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The Horizon® 3.0 TMS Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings, including physicians' offices, clinics, and hospitals.
Horizon® 3.0 TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. Its technological characteristics are described in further detail below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cerebral cortex
Dorsomedial Prefrontal Cortex
Left Dorsolateral Prefrontal Cortex
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
licensed physician
inpatient and outpatient settings, including physicians' offices, clinics, and hospitals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
- Software verification & validation of the Horizon 3.0 software updates performed in accordance with IEC 62304 and the company's quality procedure.
- Performance verification of the system therapeutic delivery to reliably and safely deliver the OCD protocol at maximum output within recognized safety temperature limits. This included modeling of the subject device (Horizon 3.0) and primary predicate device (NeuroStar) applicating coils in COMSOL and according to Finite Element Method (FEM) and statistical analysis, showing induced E-field profiles are equivalent with an average difference of ±5% at distances of 1 to 4 cm from the coil surface.
- Human Factors testing of user interface and coil positioning mechanism was performed in accordance with HE 75 and IEC 62366 and the company's quality procedure.
- No further testing for Electrical Safety, Mechanical Safety, Electromagnetic Compatibility, Alarm Systems and Biocompatibility was necessary as previous data from K211389 remains valid.
The changes to the device (updates to IFU and software for user interface and treatment stimulation parameters for OCD adjunctive treatment) do not raise new or different questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K212289 NeuroStar Advanced Therapy, Neuronetics Inc., K211389 Horizon® 3.0 TMS Therapy System, The Magstim® Company Limited
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K193006 MagVenture TMS Therapy, Tonica Elektronik A/S
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
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January 13, 2023
Magstim Company Ltd Tom Campbell Corporate Director Regulatory Affairs Spring Gardens Whitland, Carmarthenshire SA340HR United Kingdom
Re: K222171
Trade/Device Name: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0. H3.0, Horizon 3.0 with StimGuide+ Regulation Number: 21 CFR 882.5805, 21 CFR 882.5802 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP, QCI Dated: December 13, 2022 Received: December 14, 2022
Dear Tom Campbell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela D. Scott -S
Digitally signed by Pamela D. Scott -S Date: 2023.01.13 22:31:45 -05'00'
Pamela D. Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222171
Device Name Horizon 3.0 TMS Therapy System
Indications for Use (Describe)
Horizon 3.0 TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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K222171 Traditional 510(k) SUMMARY Magstim's Horizon® 3.0 TMS Therapv System
Prepared according to the requirements outlined in 21 CFR 807.92
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Magstim® Company Limited Spring Gardens, Whitland, Carmarthenshire SA34 OHR, United Kingdom Phone: +44 (0) 1994 240798 Facsimile: +44 (0) 1994 240061 Contact Person: Tom Campbell, Corporate Director Regulatory Affairs
Date Prepared: August 31, 2022
Trade Name of Device
Horizon® 3.0 TMS Therapy System
Common or Usual Name
Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions
Classification
21 C.F.R. § 882.5805, Class II, product code OBP 21 C.F.R. § 882.5802, Class II, product code QCI
Predicate Devices
K212289 NeuroStar Advanced Therapy, Neuronetics Inc. (Primary Predicate Device), 21 C.F.R § 882.5802, QCI K211389 Horizon® 3.0 TMS Therapy System, The Magstim® Company Limited (Secondary Predicate Device ), 21 C.F.R § 882.5805, OBP
K193006 MagVenture TMS Therapy, Tonica Elektronik A/S (Reference Predicate), 21 C.F.R ട്ട 882.5802, QCI
Device Description
The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, maqnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. ("TMS").
The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from antidepressant medication in the current
4
episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The Horizon® 3.0 TMS Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings, including physicians' offices, clinics, and hospitals.
Horizon® 3.0 TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. Its technological characteristics are described in further detail below.
Intended Use & Indications for Use
The Horizon® 3.0 TMS Therapy System is intended to produce and deliver non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex.
Horizon® 3.0 TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Technological Characteristics
Horizon® 3.0 TMS Therapy System and its technological characteristics remain almost identical to that cleared within K211389.
The proposed changes to Horizon 3.0, for adjunctive treatment of OCD, are limited to updates to the IFU and software for user interface and treatment stimulation parameters. Both these changes are made to facilitate safe and effective treatment of patients with OCD and do not raise new or different questions of safety and effectiveness.
The coil positioning mechanism of action with Horizon 3.0 also remains unchanged with two options available dependent on Horizon 3.0 configuration. Horizon 3.0 with StimGuide+ offers the ability to locate and determine MT and the location of the treatment location with the use of stereotactic navigation, where standard Horizon 3.0 uses the conventional manual measurement approach.
All other aspects of the device compared to the currently marketed Horizon 3.0 device remain unchanged and are identical.
5
Non-clinical Testing
Due to the minor nature of changes to the current Horizon 3.0 device, only a limited amount of non-clinical testing was necessary:
-
- Software verification & validation of the Horizon 3.0 software updates. The software modification was performed in accordance with IEC 62304 and the company's quality procedure, which is considered a well-established method via the utilization of a recognized international standard (FR Recognition Number 13-79) and the utilization of the development strategy used in the software development of the most recently cleared Horizon 3.0 device (K211389).
-
- Performance verification of the system therapeutic delivery. Testing was performed to verify that Horizon 3.0 could reliably and safely deliver the OCD protocol, at maximum output whilst remaining within recognized safety temperature limits. The verification protocol and test limits are well-established methods via utilization of a recognized international standard (FR Recognition Number 19-46) for the safety limits and K182853 for the verification protocol.
- a. In addition to OCD protocol performance testing, the subject device (Horizon 3.0) and the primary predicate device (NeuroStar) applicating coils were modeled in COMSOL and according to Finite Element Method (FEM) and statistical analysis, the induced E-field profiles are equivalent and have an average difference of ±5% at distances of 1 to 4 cm from the coil surface. The data provided is consistent with the FDA's quidance "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS)."
-
- Human Factors testing of user interface and coil positioning mechanism was performed in accordance with HE 75 and IEC 62366 and the company's quality procedure, which is considered a well-established method via the utilization of a recognized international standard (FR Recognition Number 5-57 and 5-114) and the utilization of the validation strategies used in the development of the most recently cleared Horizon 3.0 device (K211389).
The testing performed is both described in the software section (Section XVIII) and performance testing section (Section XX).
No further testing for Electrical Safety, Mechanical Safety, Electromagnetic Compatibility, Alarm Systems and Biocompatibility was necessary as previous data submitted as part of K211389 premarket notification remains valid to demonstrate safety and effectiveness and support a determination of substantial equivalence. This is re-iterated in Sections XII, XIV, XVII and XIX.
Substantial Equivalence
Horizon 3.0 device changes are limited to updates to the IFU and software for user interface and treatment stimulation parameters. Both these changes are made to facilitate safe and effective treatment of patients with OCD and do not raise new or different questions of safety and effectiveness. Information on these changes can be found in the software section, Section XVIII.
Where the labelling has been updated, this has been performed appropriately to identify various contraindications and instructions relevant to the usage of the device for treatment of
6
OCD as per special controls. Confirmed to be equivalent to that of the reference predicate (K193006), the well-established method used to update the labeling to extend the indication to include OCD does not raise new or different questions regarding safety and effectiveness. Labelling can be found in Section XV.
The focus component of both the subject device and the primary predicate device when considering the extension to the indication to include OCD is the stimulating coil.
Whilst the coil construction characteristics of the Ez Cool Coil and the NeuroStar Advanced Therapy are different, the magnetic field characteristics of the coils are equivalent which is pertinent to treatment delivery effectiveness. Earlier in K143531, the FDA determined that Magstim figure of eight stimulating coils are substantially equivalent to the NeuroStar Advanced Therapy System coil for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from medication in the current episode. This decision was later further substantiated in a retrospective open-label study titled "Comparative Efficacy of Repetitive Transcranial Magnetic Stimulation for Treatment of Depression Using 2 Different Stimulation Devices: A Retrospective Open-Label Study" where the authors Oliveira-Maia, Garcia-Guarniz, et al, conclude in that there was no statistically significant differences between outcomes in Magstim and NeuroStar treated patients which is suggestive of equivalent antidepressant efficacy between devices.1
To further substantiate this argument, the Horizon 3.0 Ez Cool Coil and the NeuroStar Advanced Therapy Coil were modeled in COMSOL and according to the finite element modelling (FEM) and statistical analysis, the induced E-field profiles by the Horizon 3.0 Ez Cool Coil and NeuroStar Advanced Therapy Coil are equivalent and have an average difference of ±5% at distances of 1 to 4 cm from the coil surface. The modeling method is based on well-established scientific methods, equivalent to those used to demonstrate equivalence for the reference predicate (K193006). For further information on the modelling, please refer to Section XX.
Coil positioning mechanism is identical to that of the Primary Predicate (K211389) where non-clinical testing according to international standard JEC 62366-1 (5-114) and HE 75 (5-57) has demonstrated that representative TMS users, after a brief training session, were able to appropriately position the coil for treatment, and follow the recommended treatment definition protocol with low variability between position. Human factors testing information can be found in Section XX.
Thus, in summary, as an adjunct for the treatment of OCD, the Horizon 3.0 figure of eight stimulating coil is considered equivalent to the NeuroStar Advanced Therapy System coil cleared by the FDA in K212289 and does not raise new or different questions of safety and effectiveness.
All other aspects of the device compared to the currently marketed Horizon 3.0 device remain unchanged and are identical.
Conclusion
1 (Garcia-Guarniz AL, Sinanis A, Pascual-Leone A, Press D. Comparative efficacy of repettive transcranial magnetic stimulation for treatment of depression using 2 different stimulation devices: A refrospective open-label study. J Clin Psychiatry 2016;77:e743.)
7
In summary, the intended use and indications for use for Horizon 3.0 and it predicate devices are identical.
The minor modifications to Horizon 3.0 to extend the indications for use do not raise new or different questions regarding safety and effectiveness. Where non-clinical testing was performed, this was performed according to well established methods recognized either as an FDA recognized standard, FDA guidance document, scientific literature or via an approach previously accepted by the FDA.
Although the indications have been modified, the overall operating principles of TMS devices for stimulating the cerebral cortex remains the same. Regardless of indication, the same type of energy output is used and the same principles apply to determining a MT hotspot and positioning of the coil for delivery of brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex. The Physical State, Technical Method and Target Area for both OBP and QCI devices are equivalent in themselves.
Non-clinical test data collected via well-established methods demonstrates that Horizon 3.0 is as safe and effective as its predicate devices (K211389 and K212289).
Thus, the information and data provided in this 510(k) premarket notification submission support a finding of substantial equivalence for the Horizon 3.0 for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
A tabular comparison of device characteristics can be found on the following page.
8
| Criteria | Horizon 3.0 TMS Therapy System
(Subject of this submission) | HORIZON 3.0 TMS Therapy System
(K211389)
(Secondary Predicate) | NeuroStar Advanced Therapy System
(K212289)
(Primary Predicate) | Magventure TMS Therapy System
(K193006)
(Reference Predicate) |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | Neuronetics, Inc. | Tonica Elektronik A/S |
| Device Name | Horizon 3.0 TMS Therapy System | Horizon 3.0 TMS Therapy System | NeuroStar TMS Therapy System | Magventure TMS Therapy System |
| Clearance date | | 09/14/2021 | 05/06/2022 | 08/09/2020 |
| 510(k) number | K222171 | K211389 | K212289 | K193006 |
| Device code | OBP, QCI | OBP | QCI | QCI |
| Intended Indications Use/
Use for | The Horizon 3.0 TMS Therapy System is
indicated for the treatment of Major
Depressive Disorder in adult patients who
have failed to receive satisfactory
improvement from prior antidepressant
medication in the current episode, as wellas an adjunct for the treatment of adult
patients suffering from Obsessive-
Compulsive Disorder (OCD). | The Horizon 3.0 TMS Therapy
System is indicated for the treatment
of Major Depressive Disorder in adult
patients who have failed to receive
satisfactory improvement from prior
antidepressant medication in the
current episode. | The NeuroStar Advanced
Therapy System is intended to
be used as an adjunct for the
treatment of adult patients
suffering from Obsessive-
Compulsive Disorder (OCD). | The MagVenture TMS Therapy
System is intended to be used
as an adjunct for the treatment
of adult patients suffering from
Obsessive-Compulsive Disorder
(OCD). |
| | | OCD Treatment Protocol | | |
| Magnetic Field Intensity | 100% of the MT | N/A | 100% of the MT | 100% of the MT |
| Stimulus Frequency | 20 Hz | N/A | 20 Hz | 20 Hz |
| Stimulus duration | 2 sec | N/A | 2 sec | 2 sec |
| Inter-train interval | 20 sec | N/A | 20 sec | 20 sec |
| Number of trains | 50 | N/A | 50 | 50 |
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| Magnetic Pulses
| per Session | 2000 | N/A | 2000 | 2000 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment | |||||||||||||
| Session Duration | 18.3 min | N/A | 18.3 min | 18.0 min | Train Duration | 2 sec | 2 sec | N/A | N/A | N/A | N/A | N/A | N/A |
| Sessions/week | 5 | N/A | 5 | 5 | Inter-train Interval | 8 sec | 8 sec | N/A | N/A | N/A | N/A | N/A | N/A |
| Treatment | |||||||||||||
| Schedule | 5 daily sessions for 5 weeks, 4 daily | ||||||||||||
| sessions for 1 week. | N/A | 5 daily sessions for 5 weeks, | |||||||||||
| 4 daily sessions for 1 week. | 5 daily sessions for 5 weeks, | ||||||||||||
| 4 daily sessions for 1 week. | Burst Pulses | 3 | 3 | N/A | N/A | N/A | N/A | N/A | N/A | ||||
| Area of brain to be | |||||||||||||
| stimulated | Dorsomedial Prefrontal Cortex | N/A | Dorsomedial Prefrontal | ||||||||||
| Cortex | Dorsomedial Prefrontal | ||||||||||||
| Cortex | Bursts | 200 | 200 | N/A | N/A | N/A | N/A | N/A | N/A | ||||
| Standard Treatment Protocol | Pulse Inter interval | 20 msec | 20 msec | N/A | N/A | N/A | N/A | N/A | N/A | ||||
| Magnetic | |||||||||||||
| Intensity | 120% of the MT | 120% of the MT | N/A | N/A | Number of trains | 20 | 20 | N/A | N/A | N/A | N/A | N/A | N/A |
| Stimulus | |||||||||||||
| Frequency | 10 Hz | 10 Hz | N/A | N/A | Number of Pulses per Session | 600 | 600 | N/A | N/A | N/A | N/A | N/A | N/A |
| Stimulus | |||||||||||||
| duration | 4 sec | 4 sec | N/A | N/A | Treatment Session Duration | 3.09 min | 3.09 min | N/A | N/A | N/A | N/A | N/A | N/A |
| Inter-train interval | 11-26 sec | 11-26 sec | N/A | N/A | Sessions/week | 5 | 5 | N/A | N/A | N/A | N/A | N/A | N/A |
| Number of trains | 75 | 75 | N/A | N/A | Treatment Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | N/A | N/A | N/A | N/A | N/A | N/A |
| Magnetic Pulses | |||||||||||||
| per Session | 3000 | 3000 | N/A | N/A | Area of brain to be stimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | N/A | N/A | N/A | N/A | N/A | N/A |
| Treatment | |||||||||||||
| Session Duration | 18.8 min-37.5 min | 18.8 min-37.5 min | N/A | N/A | Horizon® MT Remote Coil | Horizon® 3.0 E-z Cool Coil | Horizon® 3.0 E-z Cool Coil (Nav) | Horizon® MT Remote Coil | Horizon® 3.0 E-z Cool Coil | Horizon® 3.0 E-z Cool Coil (Nav) | NeuroStar Stimulating Coil | Cool D-B80 | |
| Sessions/week | 5 | 5 | N/A | N/A | Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic |
| Treatment | |||||||||||||
| Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | N/A | N/A | Core Material | Air | Air | Air | Air | Air | Air | Ferromagnetic Core | Air, Liquid Cooled |
| Area of brain to be | |||||||||||||
| stimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal | |||||||||||
| Cortex | N/A | N/A | Pulse Width | 330μς | 340μς | 340μς | 330μς | 340μς | 340μς | 180μς | 290μς | ||
| iTBS Treatment Protocol | Amplitude in SMT units (Standard Motor Threshold) | 0.28 - 1.9 | 0.28 - 1.9 | N/A | N/A | N/A | N/A | 0.22 - 2.08 | 0 - 1.9 | ||||
| Stimulation | |||||||||||||
| Intensity | 120% of the MT | 120% of the MT | N/A | N/A | |||||||||
| Repetition Rate | 50 Hz (5 pulses per sec) | 50 Hz (5 pulses per sec) | N/A | N/A |
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| Frequency range (Hz) at 100% | Pulse train duration range (sec) | Inter-train interval range (sec) | Maximum # of pulses per session (cumulative exposure) | Maximum output amplitude (V/m) at a depth of 2cm below the coil surface | Maximum magnetic field strength (T) at coil surface | Maximum magnetic field strength (T) at a depth of 2cm | Maximum magnetic field gradient (dB/dt) (kT/s) at coil surface | Maximum magnetic field gradient (dB/dt) (kT/s) at a depth of 2cm |
|---|---|---|---|---|---|---|---|---|
| 1 - 20 | 0.1 - 600 | 1 - 540 | 60000 | 150 V/m | 1.0T | 0.4T | 18 kT/s | 10 kT/s |
| 1 - 20 | 0.1 - 600 | 1 - 540 | 60000 | 150 V/m | 1.0T | 0.4T | 18 kT/s | 10 kT/s |
| 0.1 - 30 | 1-20 | 10-60 | 5000 | 135 V/m nominal | 0.7T | 0.5T | 27 kT/s | 11 kT/s |
| 0.1 - 30 | Unknown | Unknown | Unknown | Unknown | 1.0T | Unknown | 31 kT/s | 11 kT/s |
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| System
Configuration | Coil
Principle for OCD | Horizon 3.0 | Horizon 3.0 with
StimGuide+ | MT Response
Principle for OCD | NeuroStar Advanced
Therapy System | MagVenture TMS
Therapy System |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indirect targeting
of treatment
target through
measured
distance and
direction (4cm
anterior) from Leg
MT Hotspot.
Measure derived
from statistical
distance of
DMPFC/ACC
from MT hotspot. | Indirect targeting
of treatment
target through
measured
distance and
direction (4cm)
from Leg MT
Hotspot using
stereotactic
navigation.
Measure derived
from statistical
distance of
DMPFC/ACC
from MT hotspot. | N/A | Visual qualitative monitoring for APB
response | Indirect targeting of
treatment target through
measured distance and
direction (4cm anterior) from
Leg MT Hotspot using
contact sensing and head
support system. Measure
derived from statistical
distance of DMPFC/ACC
from MT hotspot. | Indirect targeting of
treatment target through
measured distance and
direction (4cm anterior) from
Leg MT Hotspot using
contact sensing and head
support system. Measure
derived from statistical
distance of DMPFC/ACC
from MT hotspot. |
| Coil Positioning and MT Determination Principle for MDD | Coil
Principle for MDD | Horizon 3.0 | Horizon 3.0 with
StimGuide+ | Coil
Principle for MDD | NeuroStar Advanced
Therapy System | MagVenture TMS
Therapy System |
| | Indirect targeting
of treatment
target through
measured
distance and
direction (5.5cm)
from MT Hotspot.
Measure derived
from statistical
distance of
DLPFC from MT
hotspot. | Indirect targeting
of treatment
target through
measured
distance and
direction (5.5cm)
from MT Hotspot
using
stereotactic
navigation.
Measure derived
from statistical
distance of
DLPFC from MT | N/A | | N/A | N/A |