TMS Therapy

TMS is a non-invasive treatment where magnetic pulses are delivered to stimulate nerve cells in the part of the brain controlling emotions, which are often are either hypo- or hyperactive in patients with mental health disorders. Targeted and repeated stimulation of these part of the brain has proven to produce an clinical effect on people suffering from depression, OCD, and anxiety. TMS is also known as rTMS (repetitive transcranial magnetic stimulation) because more than one magnetic pulse is delivered to the brain during a treatment session.

TMS is FDA approved for Depression, Obsessive Compulsive Disorder, and Anxiety. Insurance currently covers the treatment of major depressive disorder in patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. MagVenture/Brainsway TMS Therapy is available based upon Doctor approval. Your doctor will use medication dosing records and depression scores among other measures to determine whether or not you are a candidate for TMS Therapy. Other specific criteria may be dictated by ones health insurance company.

MagVenture TMS Therapy is offered as Express TMS® which lasts 3 minutes or as standard TMS, lasting 19-37 minutes. Typically, one treatment is given per day, 5 times per week, over a period of 4-6 weeks. If indicated, we will also be offering the SAINT protocol for accelerated TMS for depression which consists of 10 sessions a day for 5 days for a total of 50 sessions.

You sit in a chair in a relaxed position. When the magnetic pulses are delivered you hear a clicking sound and feel a tapping sensation on your head. Many patients are able to watch television or read during treatment.

TMS treatment has a low side-effect burden in comparison to those typically experienced with antidepressants, such as weight gain and sexual dysfunction. TMS may, for some, cause headache or nausea, but you should be able to resume your daily activities right after treatment. Although TMS is typically well-tolerated, it is a medical procedure and any side effects experienced during or after receiving the therapy should be reported to your doctor.

TMS is reimbursed by most insurance providers. Their policies may, however, vary. Pre-authorization, treater requirements (MD, CMA, APRN etc.), number of drug failures, to name a few, can impact claim approvals. Always refer to your insurer’s policy guides.

A list of current criteria from major insurance companies.

1. The patient must be 18 years or older

2. Be diagnosed with severe major depressive disorder

3. Must have psychotherapy for at least 2 months (weekly sessions)

4. No history of seizure disorder or epilepsy

5. No magnetically-sensitive metal within 12 inches from the top of the head (Dental implants and disk replacements are OK)

6. Must have tried antidepressants (see the number below of how many by each insurance company):

Aetna: 2 antidepressant medications + 1 augmentation

Anthem Blue Cross: 2 antidepressant medications

Beacon: 4 antidepressant medications

Blue Shield (Magellan): 4 antidepressant medications

Cigna: 2 antidepressant medications of 2 different classes (e.g., both can't be SSRI's)

Humana:1 antidepressant medication

Magellan: 4 antidepressant medications

Medicare: 1 antidepressant

Meritain: 4 antidepressant medications

MHN: 4 antidepressant medications

Optum: 4 antidepressant medications

TriCare/TriWest: 1 antidepressant medication

United: 4 antidepressant medications

UMR: 4 antidepressant medications

TMS research has shown very promising results especially in comparison with the success rates we have with medications. In randomized controlled trials the success rate ranges from 2⁄3 to 1⁄2 of patients receiving TMS. In open-label trials, when people know for fact that they are actually receiving the TMS therapy, the response rate is higher.

The answer is a resounding no. TMS is not shock therapy. There is no shock at all in TMS. Shock therapy is ECT or Electroconvulsive Therapy. In ECT, an electrical shock is delivered to the brain to induce a therapeutic brain seizure. This is done in hospital settings and under anesthesia. This is not how TMS works. TMS uses Faraday's law of induction to induce a micro-electrical current that stimulates very specific neuronal networks in the brain. This is done by using a targeted magnetic pulse without any of the side-effects of ECT.

Usually we would reserve a more expensive treatment option to be second-line treatment. That's why the initial trials for TMS (2007) included patients who failed one or more antidepressants. For this reason the FDA approved it for treatment resistant depression based on the data they had. This doesn't mean it won't work as a first-line treatment.

About two out of three patients will maintain their response or remission 6-12 months after TMS. About one third could see a return of depressive symptoms. Some patients may require maintenance TMS therapy after their initial or repeated treatment course. It can keep patients from relapsing again into depression after their initial treatment. Maintenance TMS therapy could be once a week for a while then once every two weeks.

Stanford Study on Accelerated Deep TMS Protocol

The Stanford study on accelerated Deep Transcranial Magnetic Stimulation (TMS) is a significant advancement in the field of neurostimulation for treating major depressive disorder (MDD). This study, often referred to as the Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) trial, explored the efficacy of delivering multiple TMS sessions per day over a shorter period compared to the traditional protocol.

Dosing and Parameters

1. Accelerated Schedule: The Stanford study involved administering TMS sessions at a highly accelerated rate. Specifically, patients received 10 sessions per day, with each session spaced approximately 50 minutes apart. This protocol was delivered over a span of five consecutive days, resulting in a total of 50 sessions.

2. Intensity and Frequency: Each TMS session used high-frequency stimulation at 18 Hz, targeting the left dorsolateral prefrontal cortex (DLPFC). The intensity of the magnetic pulses was set at 90% of the patient's resting motor threshold (RMT).

3. Total Pulses: Each session comprised 600 pulses, leading to a cumulative total of 30,000 pulses over the five-day period. This high dose of stimulation is believed to induce rapid and robust antidepressant effects.

4. Neuronavigation and fMRI: The study utilized neuronavigation guided by functional MRI (fMRI) to precisely target the DLPFC. This ensured that the stimulation was accurately delivered to the brain regions most implicated in depression.

Real-World Application and Limitations

In real-world clinical settings, the level of precision afforded by fMRI and advanced neuronavigation may not be readily available. However, clinical practices can still approximate the efficacy of the Stanford protocol using available resources:

1. Standardized Targeting: While advanced neuronavigation might be lacking, standard TMS devices often come with built-in targeting mechanisms based on anatomical landmarks. Clinicians can use these standardized methods to approximate the location of the DLPFC.

2. Accelerated Protocol Adaptation: Clinics can adopt a modified accelerated protocol by increasing the number of sessions per day within practical and logistical constraints. For example, delivering 2-5 sessions per day can still provide significant clinical benefits, as evidenced by BrainsWay's real-world data.

3. Monitoring and Adjustment: Continuous monitoring of patient responses using validated rating scales (e.g., HDRS, MADRS, PHQ-9, BDI-II) can help tailor the treatment to individual needs. Adjustments in dosing intensity and frequency can be made based on patient tolerance and response.

4. Safety and Feasibility: Ensuring patient safety is paramount. Real-world settings should implement rigorous protocols to monitor adverse effects and ensure the feasibility of multiple daily sessions.

Efficacy in Less Controlled Settings

Despite the absence of highly controlled research tools like fMRI and advanced neuronavigation, real-world applications of accelerated TMS protocols have shown promising results:

1. Comparable Outcomes: As seen in BrainsWay's study, accelerated Deep TMS protocols achieved high response (80%) and remission (51%) rates, similar to those reported in controlled studies.

2. Rapid Improvement: Patients undergoing accelerated TMS protocols often experience significant improvements within a few days, demonstrating the potential for rapid symptom relief.

3. Durability of Effects: The long-term benefits of accelerated TMS, such as sustained remission and reduced relapse rates, have been observed, indicating that even in less controlled settings, the treatment can provide durable outcomes.

Conclusion

The Stanford study on accelerated TMS has paved the way for innovative treatment protocols that can be adapted to real-world clinical settings. While the exact precision of fMRI-guided neuronavigation may not be feasible in everyday practice, the principles of accelerated dosing and frequent monitoring can still be applied to achieve substantial clinical benefits. By leveraging available technologies and adapting protocols, clinics can provide effective, rapid, and safe TMS treatments for patients with major depressive disorder.