This video shows a step by step process of what a single TMS treatment looks like. The only changes that are not documented in this video are that new protocols have been recently FDA-approved and are now used with proven efficacy. Individual treatment sessions have dropped from 30 minutes to either 3 minutes or 19 minutes maximum time for the treatment of depression.
The current use of electromagnetic induction for transcranial stimulation dates back to 1985. Dr. Tony Barker and his colleagues invented the initial type of TMS in Sheffield, UK. Moreover, Barker scientifically proved the influence of magnetic stimulation on motor cortex of the human brain in 1985.
In 2002, Canadian Association of Health which is an official institution approved the medical results and benefits of rTMS. Moreover, other countries like the US, the UK, Germany and Japan have been working on this method for 20 years. At present, many different types of devices are being used for repetitive electromagnetic stimulation. The Food and Drug administration of the United States granted approval to this method on October 8th, 2008.
To read about the specific device we use, you can go to: https://www.magventure.com/us/patients-and-relatives
Repetitive TMS is a noninvasive form of brain stimulation. Unlike vagus nerve stimulation or deep brain stimulation, TMS does not require surgery or implantation of electrodes. And, unlike electroconvulsive therapy (ECT), TMS doesn’t create seizures or require sedation with anesthesia. Generally, TMS is considered safe and well-tolerated. Many of our patients receive treatments before work or during their lunch hour and return to their usual daily lives immediately after treatment.
TMS can cause some minor side effects including headaches or scalp discomfort at the site of stimulation as well as tingling, spasms or twitching of facial muscles specifically during treatment. After treatment, some tiredness can occur (usually the first week). A rare side effect are seizures. Most current data (2019) shows 1/30,000 using the MagVenture TMS Device. In any case, seizures are self limited, lasting a short amount of time, and there is former protocol in an event such as this,
The Provider will determine the ideal stimulation intensity and anatomical target by taking advantage of a “landmark” in the brain called the motor cortex. By first targeting this part of the brain, the team can determine where best to locate the stimulation coil as it relates to that individual’s brain and how intensely it must “fire” in order to achieve adequate stimulation. This process is called the Initial Motor Threshold appointment.
Calculations are then applied to translate this data toward finding the dorsolateral prefrontal cortex, the brain target with the greatest evidence of clinical effectiveness and an area known to be involved in depression.
TMS therapy is an intensive treatment option requiring sessions that occur five days a week for about 6 weeks. Each session typically lasts 19 minutes, but can be as short as 3 (for some types). When patients arrive, they may briefly check in with a technician or administrator then begin the stimulation process.
Though one session may be enough to change the brain’s level of excitability, relief isn’t usually noticeable until the third, fourth, fifth, or even sixth week of treatment. The therapy is conducted with earplugs to reduce the noise of the magnet, which makes a rapid “woodpecker”-like tapping.
Current clinical data shows 55% remission rates (50% reduction of scores) and about a 75% response rate (anything less than 50% reduction of scores). About 10% of patient are late responders and may require additional sessions till they reach remission. If treatment does not reach remission with additional sessions; other alternative treatments are recommended or referred.
Most insurances now cover TMS Therapy, however, it does vary based on whether the Provider is credentialed with a prospective patient’s current plan. Insurances are only covering patients that are 18 years or older.
Federal and state insurances can have stipulations and TMS clinics usually know what those current stipulations may be. Most require specific criteria to be met to be considered qualified for TMS Therapy.
Most clinics will request a phone screening to rule out potential barriers for insurance reimbursement as well as to see if there may be any contraindications that prohibit treatment due to safety.
If a patient is a good candidate, and insurance is not an option, there is more flexibility to receive treatment with a cash pay option. Olympia TMS offers discounted cash-pay rates and a free consultation for qualified potential candidates. Cash pay also allows us to treat ages 15 to 17 on a case-by-case basis.
The most common symptoms of depression are the presence of empty, sad or irritable mood in combination with both cognitive and somatic changes that can significantly affect the individual’s capacity to function. These behavioral and functional consequences of depression are due to alterations in brain activity.
In depression, a whole distributed network of brain areas is affected. The cardinal idea of applying TMS for treatment of depression is to precisely target the areas of the brain involved in MDD. The part of the brain that is being stimulated is located to the left side of the brain, specifically the dorso-lateral prefrontal cortex, or in short Left-DLPFC. This cortical area is the prime target for CE and FDA approved TMS treatment, as it is a focal point connecting all the different brain areas that are involved in the pathology of depression.
Once the brain has gone through a full cycle of TMS Therapy, it is still making new connections post-treatment.
Olympia TMS has received FDA clearance for both TBS (treatment time 3 minutes) and standard TMS (treatment time between 18.8-37.5 min)
For Express TMS® (TBS treatment), the core of the system consists of:
For standard TMS, the core of the system consists of:
The system furthermore includes:
It is possible to get the Patient Management system MagVita 360 which is an optional add-on to the TMS Therapy system.
Indications for use
Olympia TMS Therapy 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.
Express TMS® (TBS treatment):
TBS stimulation is applied in 50Hz triplet bursts five times per second. It is an intermittent theta burst stimulation (iTBS) which means that the stimulations are delivered in a cycle of 2 seconds on and 8 seconds off. One treatment session consists of: 10 burst per train at 5Hz – duty circle: 2 seconds on, 8 seconds off, over 3 minutes and 9 seconds. One burst consists of triplets (3 pulses) of 50Hz and IPI (Inter pulse interval) of 20ms. The number of trains is 20 which provide a total of 600 pulses and 200 bursts in the treatment session. These TBS sessions are repeated once daily, 5 times per week for 6 weeks.
Standard TMS:
Olympia TMS’s FDA clearance is a 510(k) “Substantial Equivalency” clearance with the Neurostar TMS therapy device from Neuronetics as the predicate device. One treatment session consists of 75 cycles of 4 seconds of 10Hz stimulation followed by between 11-26 seconds of rest. The stimulation intensity is 120% of the patient’s resting Motor Threshold (MT) value. The overall protocol results in a session duration of between 18.8- 37.5 minutes with a total of 3,000 pulses delivered. These sessions are repeated once daily, 5 times per week for 6 weeks.
Theat burst stimulation (TBS) is a form of patterned TMS which makes it possible to induce strong and long-lasting effects using a lower stimulation intensity and a shorter time of stimulation compared to standard TMS protocols. This means that if you use TBS instead of standard TMS to treat your patients, you will be able to treat 5 times more patients which makes TBS depression treatment much more cost-effective.
In the FDA cleared TBS protocol, the theta burst stimulation is applied in 50Hz triplet bursts five times per second. It is an intermittent theta burst stimulation (iTBS) which means that the stimulations are delivered in a cycle of 2 seconds on and 8 seconds off. This pattern is found to have an excitatory effect whose potency matches or exceeds much longer sessions of standard TMS.
Olympia TMS Therapy is as safe and effective as the predicate device for use in treatment of major depressive disorder as per the information supporting Olympia’s 510(k) FDA clearance. The safety and efficacy of the Olympia TMS stimulator is supported by ample data from independent academic medical centers worldwide, where it has been used extensively in clinical practice for the treatment of Major Depressive Disorder.
Express TMS® (TBS treatment)
The FDA cleared TBS protocol specifies a treatment session lasting 3 min and 9 seconds. Because of the highly efficient liquid cooling included in the TMS system, the patient throughput is very high as it is not necessary to wait for the system to cool down between treatments. It is possible to treat between 35-60 patients per day depending on the number of working hours. Based on a 10 minute slot per patient, it is possible to see 6 patients every hours.
Standard TMS
The FDA cleared protocol specifies a treatment session lasting between 18.8-37.5 minutes. Because the TMS system relies on a remarkably efficient liquid coolant system to maintain the temperature of the coil, there is no need to delay operations between patients to allow the system to cool off between treatments. This allows for a high patient throughput and for high volume practices to see 15-20 patients per day, without any issues related to system heating.
The “consumable cost” per session, using the Olympia TMS Therapy system is approximately $4.38 for standard TMS and less than $1.50 for TBS. This price is based on the complete TMS depression therapy protocol consisting of 30 treatments and includes the replacement of the treatment coil as well as an individual treatment cap for each patient. For further details, please see breakdown of the TMS Therapy cost below.
Express TMS® (TBS treatment)
The treatment coil used during the therapeutic procedure has a lifespan of approximately 11,250 treatment sessions before replacement. The cost per treatment is therefore approximately $0.90. In addition, each patient receiving TMS Therapy is assigned a treatment cap. The cap is used throughout the 30 session course of treatment. At a cost of $14 per cap, an additional cost of $0.47 is added per treatment.
Standard TMS
The treatment coil used during the therapeutic procedure has a lifespan of approximately 2,250 treatment sessions before replacement. The cost per treatment is therefore approximately $3.91. In addition, each patient receiving TMS Therapy t is assigned a treatment cap. The cap is used throughout the 30 session course of treatment. At a cost of $14 per cap, an additional cost of $0.47 is added per treatment.
TMS procedures delivered with the Olympia TMS Therapy system are billed using the same CPT codes as procedures delivered with other FDA cleared TMS systems. As long as standards for medical necessity* are met, there is no rationale for insurance companies that cover TMS as a medical procedure for the treatment of depression, to deny re-imbursement for therapy delivered with the Olympia TMS system. However, different standards for medical necessity do exist and may vary from insurance company to insurance company.
* The Olympia system has been established and is recognized in the United States by the clearance granted to Olympia to market the Olympia system as a device to be used for the delivery of rTMS for the treatment of depression by the US Food and Drug Administration (FDA). The Olympia TMS Therapy System is “indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressants in the current episode”.
Yes – the Olympia 360 is a patient management system especially developed for use in a clinical settings. It is an optional add-on to the Olympia TMS Therapy. With the Olympia 360, it is possible to get anytime, anywhere access to the system from all platforms such as laptops and tablets. With the Olympia 360 you can manage your patient’s data, treat your patient as usual and log the data, track your patient’s treatment and use the report tool for reimbursement purposes.
One day of onsite training is included with all Olympia TMS system purchases. The training includes a complete set-up of the system, training on the care and maintenance, navigation of the system interface, and clinical aspects of use, such as patient qualification (indication for use, contraindications), finding MT hotspot, determination of MT intensity level, location of treatment location based on MT hotspot, and safety preparedness in case of adverse events during TMS sessions.
For practical reasons and concerns of patient privacy, a dedicated treatment room is highly recommended. The Olympia TMS Therapy system has a footprint of approximately 3 square meters and the TMS procedure makes a clicking sound that would almost certainly interfere with other activities that might be conducted simultaneously in the same treatment space.
The Olympia TMS Therapy system includes a tool which provides the correct translation from the “Motor Threshold Hotspot” to the therapeutic treatment location on the left dorso-lateral pre-frontal cortex when it is used in conjunction with the included C-B60 coil (for motor threshold determination).
The Olympia TMS Therapy system offers a special system which not only stabilizes the patient’s head but also helps ensure that the patient is comfortable during the treatment session. The system consists of an optional flexible pillow filled with small polystyrene balls. The pillow is molded around the patient’s head and neck before the air is evacuated. The pillow will hereby become rigid and will effectively support the patient’s head and prevent any side to side motion that might allow unwanted patient movement relative to the treatment coil. The treatment coil, which is placed on the front of the patient’s head, further stabilizes the patient’s head against any forward/ backward motion.
