Theta Burst Stimulation: A new treatment for Resistant Depression approved by the FDA

What is Transcranial Magnetic Stimulation (TMS)?

Transcranial Magnetic Stimulation (TMS) is a non-invasive, non-pharmacologic neuromodulation technique that uses the magnetic field to stimulate or inhibit specific areas of the brain. A magnetic pulse can painlessly penetrate the treated person's skull and reach the cerebral cortex, inducing a stimulatory current capable of modulating the activity of neuron cells.

Depending on the chosen parameters for stimulation, the effect on the brain can be of two types:

1. Activation - induction/increase in the electrical activity of an otherwise inactive or hypoactive area;

2. Inhibition - reduction of the ongoing electrical activity in a given hyperactive area.

Several laboratory studies suggest that the modulation action of neuronal activity achieved by TMS is accomplished through enhancement and potentiation of Brain Derived Neurotrofic Factor (BDNF; an important factor involved in neuronal cell plasticity) activity through an action on its TrkB receptors, thus suggesting that the benefits obtained through this neuromodulation technique can be attributed to an improvement in brain plasticity.

Types of TMS

There are different types of TMS, to achieve the specific therapeutic goal set for each patient effectively:

• Repetitive Transcranial Magnetic Stimulation (rTMS);

• Theta Burst Stimulation (TBS);

• Theta-Burst Multi Session Treatment (SNT);

• Deep Transcranial Magnetic Stimulation (Deep TMS);

At Dr. Pallanti's Istituto di Neuroscienze, we operate on the full range of TMS for the treatment of psychiatric disorders. In addition, we are the only facility in Italy that makes use of Neuronavigation to localize the target of stimulation, thus succeeding in significantly increasing the precision of treatment.

Learn more about the features of different types of TMS offered by the Istituto di Neuroscienze.

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The Theta Burst Stimulation Protocol ― A Breakthrough in Depression Treatment

The FDA (Food and Drug Administration) approved the Theta Burst Stimulation for the treatment of Major Depressive Disorder (MDD), which has opened promising new possibilities for treating cases of depression resistant to conventional therapies.

Access to treatments that require just a few minutes a day provides individuals with more opportunities for care and, as a result, significantly improves their quality of life.

What is the Theta Burst Stimulation protocol?

The Theta Burst Stimulation protocol is a new and promising method of administering Transcranial Magnetic Stimulation (TMS), which, in many cases, has proven to be more efficient and longer lasting than standard TMS. Unlike standard TMS, the Theta Burst Stimulation protocol uses a series of high-frequency magnetic pulses, allowing for more effective and long-lasting brain stimulation.

Thanks to the specific type of high-intensity magnetic stimulation used in the Theta Burst Stimulation protocol, treatment of symptoms generally takes less time, offering greater accessibility to care for patients in terms of cost and time required.

The efficacy of the Theta Burst Stimulation protocol

During the approval process of the Theta Burst Stimulation protocol, the FDA assessed its safety and efficacy through a clinical study involving 146 participants with Major Depressive Disorder (MDD), 80 of whom received a standard TMS protocol. In contrast, the other 66 received a Theta Burst protocol.

Data analysis from this study showed that the Theta Burst Stimulation protocol is as effective as standard TMS in reducing depression symptoms. Participants in both groups achieved statistically significant reductions in depression symptom scores, meeting the equivalence criteria required to approve the shorter Theta Burst Stimulation protocol.

How the Theta Burst Stimulation protocol works

The innovative Theta Burst Stimulation protocol ― available at Dr. Pallanti's Istituto di Neuroscienze ― uses a coil to stimulate or inhibit neurons in the cerebral cortex through consecutive sets of high-frequency magnetic pulses.

Through this kind of TMS, it is possible to provide two different types of protocol that are capable of achieving opposite effects on brain cells:

• Continuous Theta Burst Stimulation (cTBS): capable of reducing brain activity of brain cortical regions of interest;

• Intermittent Theta Burst Stimulation (iTBS): capable of increasing brain activity of brain cortical regions of interest.

Each therapy session lasts less than 5 minutes, and over a single day, 4-7 sessions can be performed, depending on the patient's needs. The typical initial treatment cycle requires at least 20 days of treatment. However, the overall duration of the treatment protocol may need to be adjusted according to the person's response and thus require an increase in total treatment sessions.

Since this therapy has no contraindications, generally, the more treatment sessions, the better the results; at the end of the initial treatment cycle, it is essential to schedule regular booster sessions to consolidate therapeutic progress and prevent relapses.

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