By: Richard Bermudes, M.D. & Roger Pottanat, M.D.
Since 2008 the number of TMS systems marketed for treatment resistant depression (TRD) in the United States is now at seven. There are a number of other TMS systems which are marketed worldwide for a variety of neuropsychiatric conditions. Each device has their own unique attributes to their system structure, business model and the ongoing support offered. This article proposes a framework by which to evaluate the various TMS systems in use.
Safety/ Risk: TMS is a relatively safe procedure. Safety of TMS is dependent on delivering treatment within a set of specific safety parameters to a specific cortical target for a specified amount of time over a specified duration of treatment.
- What are the treatment parameters that the system is capable of providing?
- Are these the treatment parameters that the clinician intends to use?
- Does the system have a method to indicate to the user that the system is programmed appropriately and safely?
- How does the system monitor pulse number and temperature of the coil?
- Does the system allow for treatment to proceed outside of the established safety guidelines or preprogrammed parameters?
- How is the coil secured in place?
- Does the system indicate the proper cortical target?
- Does the system utilize a separate coil for MT determination vs. treatment?
- Does the system use a visual, EEG-guided, EMG-guided or neuronavigational localization?
- How does the system store each patient’s treatment site: caps, measurements on device or neuronavigational systems?
- Does the system allow for treatment when the coil is positioned too close or on the motor cortex or is off the proper clinical target?
Benefits/ Efficacy: A device is clinically effective when it produces the effect intended by the manufacturer relative to the medical condition. At present, all TMS systems provide FDA clearance by demonstrating “substantial equivalence” to the Neurostar TMS System.
- Is there a specific sham-controlled data set showing efficacy for a specific clinical condition with the specific TMS system? Is this data published in a peer reviewed journal?
- Is the TMS system considered equivalent to a system that has high grade efficacy data?
- Does the distribution of the E-field, induced by the magnetic field, influence treatment outcomes or safety?
Performance can be thought of as the technical functions of the system in addition to the clinical effectiveness.
- Does the system perform in a clinical setting and patient population that the clinician intends to use the system in?
- How adaptable are the treatment parameters and during which points during the treatment session are they adjustable?
- What are the performance parameters of the coil, capacitors, cooling system, positioning system and other components of the stimulator?
- If a system offers multiple coils, which coils are FDA cleared for which indications?
- Does the system or coils have CE (European Conformity) or other appropriate clearance?
Other Variables: There a multitude of variables that differ between companies marketing a TMS device for clinical use.
- Patient Data Management
- How are the patient’s data and treatments stored?
- Is there reporting software?
- Can the system integrate with an EMR?
- Footprint/ Facility Requirements
- How large is the system?
- Does it come with a chair or must one be purchased?
- Will changes need to be made in the facility?
- Is the device easily mobile or what would be required to move the device in the future?
- Business Model/ Cost
- What are the capital equipment costs?
- Are there per treatment costs with the capital costs?
- Are there costs to replace coils or other parts?
- What is the shelf life? Over what period should one depreciate the equipment.
- Are there customer service contracts and what are the associated costs?
- Are there financing plans that are vendor sponsored or is there a partnership with a capital lease company?
- Are there any promotional discounts or buy-back programs?
- Is there a team that offers assistance with payors, payor policies and contracting?
- How quickly can patients be treated?
- Can patients that require high stimulator output be treated efficiently?
- Customer Service/ Device Performance Monitoring
- What does the service contract include and what does it exclude?
- How quickly can the system be serviced?
- Is there a service technician in your local area?
- Physician and Technician Training
- What training is offered for physicians and technicians?
- What kind of system controls are in place for technicians?
- How easy is motor mapping with the system?
- Is there Medical Director Support?
- Device Lifespan/ Product Updates
- How often are updates expected for the system?
- How much downtime would an update or regular maintenance require?
- How long would the device be expected to last before requiring replacement?