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ADDITIONAL INFORMATION
16 Minutes
CONTENTS
CONTENTS
Psychiatric illnesses are a leading cause of morbidity and disability around the globe. Over the years, a variety of allopathic medications have been trialed and most of them have met with tremendous success. Research data suggests that a vast majority of patients with depression have experienced adverse side effects of antidepressant medications and some of them would just prefer a more natural method to manage their psychiatric illness.
What are the options for patients with depression who do not tolerate the mainstay medications of allopathic treatment? For decades, shock therapy or electroconvulsive therapy (ECT) has been the cornerstone of managing refractory cases of depression. As a matter of fact, ECT is still thought to be one of the most effective and potent treatments for psychiatric conditions. However, ECT is even harder to tolerate and it has serious long-term adverse effects on cognition and memory. Today, for many patients with depression who had a suboptimal symptom relief with psychotherapy and medications alone, there is a much more convenient and safe treatment modality available, called Transcranial magnetic stimulation (TMS).
Transcranial magnetic stimulation (TMS) is a safe, effective, convenient, and noninvasive method of brain stimulation therapy. It is frequently advised for people with depressive disorders whose symptoms have not been sufficiently relieved by antidepressant medication and/or psychotherapy. TMS devices generate magnetic energy which is transformed into electrical current beneath the patient’s skull to help manage the patient’s emotional state. The device operates outside the body and uses powerful magnetic fields to stimulate neuron cell bodies in specific areas of the brain. The US Food and Drug Administration (FDA) approved TMS as a treatment modality in 2008.
TMS Treatment for Depression and Anxiety
It has research-proven benefits as in various clinical trials after six weeks of treatment, 1 in every 2 patients with depression showed significant improvement whereas 1 in 3 patients had complete relief of symptoms. TMS therapy is indicated in patients who are either unable to tolerate the side effects of antidepressant medications such as decreased libido, sexual dysfunction, weight gain or they are non-compliant with a daily dose of medicines in case of a comorbid condition.
The application of TMS is twofold; can be used alone effectively in selected patients while in others, a combination of TMS and medications has an agonist effect in increasing the efficacy of the oral medication. It is a highly convenient modern-day office treatment that does require anesthesia and the patients usually resume routine activities right after the treatment session.
Although the precise mechanism of how TMS works is not fully understood, the nerve fibers in the central nervous system are stimulated with each pulse of electromagnetic current that traverses through the skull to the brain. A transient activity of the brain cells under the treatment coil is prompted. It appears to generate changes in neurons in regions of the brain implicated in mood regulation such as the prefrontal cortex.
This alters the biological function of the brain by enhancing the release of specific neurotransmitters that are deficient in individuals with depression. This in turn seems to improve mood and alleviate the symptoms of depression. Depending on the frequency and amplitude of the magnetic pulse delivery, the biological activity of the brain can be influenced to varying levels with regard to the type and severity of symptoms. It has also been suggested by some of the recent studies that eliciting the right and left hemispheres of the brain to have variable effects on the mood of the patient.
In an outpatient setup or a medical center, during a TMS session, a trained technician or a physician places an electromagnetic coil against the scalp near the forehead. The electromagnet coil will deliver a magnetic pulse that elicits nerve cells in the region-specific to mood. As a painless, highly convenient procedure, general anesthesia is not required. The patient is awake throughout the procedure and barely feels anything over the scalp.
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There might be some clicking sounds when the device starts delivering the magnetic impulses. Each session can last for 20 to 40 minutes. There is no downtime and routine activities can be immediately resumed. Generally, a total of 5 sessions per week for about 6 weeks are required for significant results. There are various methods to perform the TMS procedure, and techniques may change slightly with different experts.
Mental health is still stigmatized in many parts of the world and only a fraction of patients suffering from depression would seek medical treatment. Among these, more than 30% fail to achieve reasonable improvement. Medications or psychotherapy are not suitable for all patients.
About 25% of individuals with depression will not respond to several trials of medication therapy either due to a lack of efficacy or compliance to medication. Similarly, a vast majority of patients have failed to respond to psychotherapy due to a lack of follow-up or a dearth of financial resources and/or time. Other treatment modalities are vital in addressing the unending needs of patients who suffer from the devastating effects of depression.
Some of the key benefits of TMS therapy over the more conventional ECT (electroconvulsive therapy) include:
The TMS therapy was approved by FDA after 13 years of clinical trials mostly in the United States. The company that created the first Transcranial Magnetic Stimulator machine was Neuronetics Inc. The machine is called NeuroStar. To date, it remains a state-of-the-art machine that has earned significant recognition among practitioners and patients. The FDA approved these magnetic stimulators to deliver electromagnetic pulse at a frequency of 10 Hz for 37.5 minutes including breaks.
FDA approved a second machine that was manufactured by a company called Brainsway. The claims for this pulse generator machine were slightly different. The manufacturers claimed that the pulse generated by this machine would reach much deeper brain structures than its counterpart NeuroStar. In strictly technical terms, these claims are only theoretical as it has not been scientifically proven that the Brainsway machines hit a deeper part of the brain.
That being said, the spherical models of Brainsway claim that in comparison with other machines, they have achieved a further deeper stimulation of brain structures (about 0.7 centimeters) with their deep TMS devices. One of the main advantages marketed for using Brainsway machines was the short treatment length as it is employed for 20 minutes compared to 37.5 minutes for conventional TMS machines. This allows the practitioners and physicians to decrease the interval time in between stimulations so the TMS sessions could practically be half as long.
Several studies do show a higher efficacy of Deep TMS. Apart from stimulation of deeper structures, stimulation of a much larger portion of the brain with each pulse is also predicted. On the contrary, a study published in 2017 found out that patients reported a greater decrease in depressive symptoms from Surface TMS compared to Deep TMS. Patients were also more confident in undergoing Surface TMS therapy. Likewise, practitioners who worked on both devices reported that Surface TMS therapies have fewer side effects compared to Deep TMS.
TMS therapy is generally well-tolerated. Over the last few years, it has been linked with fewer side effects and a bare minimum percentage of patients stop treatment because of the side effect. The most common side effect reported by almost half of individuals treated with TMS is a headache. This is usually mild and would generally diminish over the course of the treatment session. Over-the-counter oral analgesics can be advised by the practitioner for the subtle post-procedure symptoms. The most severe side effect of TMS therapy is generalized seizures, though the risk of getting a seizure is extremely low.
One of the downsides of TMS therapy is the longer period of treatment. The time required for a full course of TMS treatment is 5 days per week for 6 weeks. Also, procedural anxiety (before and during treatment) is an add-on side effect in comparison with medication therapy. As a costly procedure, sometimes the patients will complain about the issues with their insurance coverage of TMS therapy.
In comparison with the more invasive ECT which has well-documented side effects, there are no distinguished long-term side effects of TMS therapy. Generalized seizures are a potential long-term serious side effect but the chances of seizures with TMS therapy alone are extremely low. That being said, TMS therapy has not been linked with the most usual side effects of antidepressant medications including sexual dysfunction, sedation, GI upset, weight gain, and dry mouth.
Like with all other procedures involving magnetic currents (for instance, MRI), TMS therapy is not recommended for patients with any type of non-removable metal device in their head or facial skeleton. Some exceptions to these are dental fillings and braces. Likewise, TMS therapy is not advised to patients who have has a seizure in the past. In case such negligence is practiced, a serious injury or even death can occur with the object malfunctions and heats up inside the body. These metal implants/devices include but are not limited to:
TMS therapy is a fairly new treatment modality. Ongoing research data has shown amazing results regarding its efficacy. A recent systematic review showed that a total of 9 studies reported 63% of individuals noticed significant relief of depression symptoms who had undergone TMS treatment. In the same study, response rates post TMS therapy for 5 weeks were found to be 70.6% and the remission rates were 41.2%.
Some studies conducted on depression questionnaire scores showed that it reduces depression scores significantly by up to 40-50%. Numerous high sample studies on TMS therapy advocates that it is effective in improving symptoms of depression. In one study of relapse rates after six months conducted with 204 patients, the relapse rates of patients who had undergone TMS therapy were 22.6%. This means that about 80% of patients were symptom-free at six months period post TMS.
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In another observational study including 42 clinical settings where 307 patients identified with medication-resistant Major Depressive Disorder received up to 6 weeks of TMS therapy. Patient on three symptom assessment scales; the Patient Health Questionnaire, Inventory of Depressive Symptoms Self Report, and the Clinician Global Impressions Severity of Illness scale. The reported results showed statistically and clinically significant improvement in response as well as remission rates after TMS therapy.
Studies have also shown considerable response of patients with generalized anxiety disorder. In a study conducted by the neurosurgery department in University hospital Belgium, the scientists found out that anxiety scores decreased significantly by 33% along with a 40% reduction of depression scores, 45% decrease in tension levels, and 44% in fatigue. Similar studies could be found for other psychiatric illnesses, advocating the ‘off-label’ use of TMS therapy beyond Major Depressive Disease.
TMS therapy has been regarded as a safe procedure by the National Institute of Health. It was approved by FDA as a treatment for Major Depressive Disorder. While it is an FDA-approved procedure for depression only, for many years it has been safely used “off-label” to manage other disorders including generalized anxiety, PTSD, schizophrenia, obsessive-compulsive disorder, and bipolar disorder.
Research data has shown that a vast majority of patients have a good tolerance for TMS therapy. As a matter of fact, TMS therapy does not carry many of the serious and rather common adverse effects of other treatment options for depression. Unlike deep brain stimulation or Vagus nerve stimulation, for instance, it does not involve an invasive procedure for implantation of electrodes nor does it require anesthesia or sedation for long hours. TMS therapy is not linked with the numerous serious potential side effects of antidepressant medications, including GI upset, sexual dysfunction, sedation, weight gain, or dry mouth.
TMS therapy is a fairly recent but safe and effective addition to the management plan of psychiatric illness particularly Major Depressive illness. It is FDA approved procedure for depression since 2008. It does not require anesthesia as it is a non-invasive procedure. Unlike its counterpart ECT or Vagus nerve stimulation, it is better tolerated in patients of all ages. It is a highly convenient outpatient procedure with little to no downtime.
The patients can drive themselves to and from the practitioner’s clinic and resume routine activities almost immediately. One of the most common rationales for TMS therapy in treatment-resistant depression. After multiple trials of antidepressant medications, the patients would usually develop resistance to allopathic treatment. It has been scientifically proven that TMS therapy augments and potentiates the effects of antidepressant medications and psychotherapy. There are no serious short-term or long-term side effects associated with TMS therapy.
The side effects are mostly transient and limited to the duration of TMS sessions only (20-40 minutes). The most common complaint of the patients undergoing the TMS therapy is a mild headache during the procedure and it occurs only rarely after the procedure. It can be relieved with prophylactic pain medication or medications taken after the procedure. Patients may experience a subtle twitching of the facial muscles during the procedure. Redness of facial skin or a warm feeling is another transient side effect.
This usually occurs at the site of coil placement due to the heat generated by the headpiece Patients might hesitate due to pre-procedural anxiety or mental discomfort due to unfamiliarity with the procedure. One of the downsides of the TMS procedure is the time required for a full course of treatment. For an effective response and remission, it is usually recommended for 6 weeks (30 treatments) with 5 sessions per week. A minority of patients would also complain about their insurance coverage of TMS therapy. It has generally been observed that patients who are resistant to multiple mainstay medications would not face any problems from the health insurance providers.
ECT and TMS therapy have a considerable difference in terms of mechanism of action. ECT is the application of electric current directly to the patient’s head while they are immobilized and sedated. It causes an intentional ‘therapeutic seizure’ with the aim to alter the firing function of neurons in the brain. ECT is often associated with short-term cognitive side effects. Likewise, potential adverse effects include nausea, headaches, muscle aches, brief changes in heart rate, transient arrhythmias, and changes in blood pressure. Long-term side effects are rare but memory deficits are a potential complication.
With better alternatives available, currently, ECT has rarely been considered a first-line treatment except for sudden onset, rapidly deteriorating cases of depressive illnesses, or for patients with multiple complex psychotic illnesses. The risks involved and the invasiveness of the ECT procedure require patients to limit their activities, take leave from work, and in some cases hire a dedicated caregiver or get hospitalized for the period of recovery.
On the contrary, TMS does not involve the direct application of electric currents to a widespread region of the brain. TMS therapy targets a more focused anatomical location to activate the healing process of the brain more gently by magnetic currents while preventing cognitive dysfunction and generalized seizures. TMS therapy has much fewer adverse effects, thereby allowing patients to stay comfortable and awake during treatment sessions.
TMS therapy also allows patients to live independently, resume routine activities and return back to work immediately, and continue other remission-promoting treatment modalities alongside such as psychotherapy and antidepressant medications. Performing routine activities during a course of ECT is extremely hard, and that is one reason why most patients would feel ECT being too extreme for their depressive symptoms.
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