Since the 1980s, Transcranial Magnetic Stimulation (TMS) has been used to study the nerve fibers that carry information about movements from the brain to the spinal cord and on to the muscles. In the late 1990s, physicians began to explore the therapeutic potential of TMS for the treatment of a variety of diseases, with depression being the most thoroughly studied. Since then, more than 20 randomized, controlled trials studying TMS as a treatment for depression have been published by researchers throughout the world. TMS became a standard of practice in the United States when it was cleared by the FDA in 2008 after a decade of clinical trials. TMS Therapy was cleared as an appropriate treatment option for adult patients with Major Depressive Disorder who failed to achieve satisfactory improvement from at least one prior antidepressant medication at or above the adequately effective dose over an adequate duration.
TMS is often prescribed to patients who have not improved with traditional treatments. However, TMS is increasingly being seen as a first line treatment and more doctors are prescribing TMS Therapy before prescribing medications, or alongside medications. The administering of TMS is very precise and well regulated. Treatment is always performed by a trained TMS technician under the supervision of a TMS prescribing psychiatrist or doctor. TMS Therapy does not require surgery, anesthesia, or sedation. Patients are fully conscious and awake throughout the TMS sessions, and the sessions are typically delivered in the supervising doctor or psychiatrist’s office on an outpatient basis. After TMS sessions patients are able to resume normal activities, like work or driving, without interruption.
It should be noted that in cases where severe depression remains after TMS Therapy, patients have been recommended Electroconvulsive Therapy, or ECT. For this and other reasons, ECT is often confused with TMS. While ECT can be highly effective, it is also highly invasive. Some patients suffer unwanted side effects, including memory loss or severe headaches. Antidepressants also have numerous side effects such as nausea, diarrhea, insomnia, sedation, lack of emotion, and sexual problems. In addition, antidepressants are systemic, meaning that the medicine enters the body and bloodstream.
TMS Therapy has very little to no side effects, does not require any anesthesia or sedation, and is non-systemic as well as non-invasive. Non-invasive, meaning that it does not involve surgery - the patient remains awake and alert through the duration of treatment and can resume normal activities immediately following treatment. Non-systemic, meaning nothing enters your bloodstream. There is no need for chemicals or substances to circulate throughout the body. TMS is perhaps the least intrusive form of depression therapy available. Patients can immediately return to regular activity after TMS sessions. The typical initial course of treatment is about 37 minutes daily over 4-6 weeks.
It is important to note that in clinical trials that studied the effectiveness of TMS Therapy, half of the patients had been treated with at least four medication treatment attempts, one of which was at an adequate dose and duration. TMS Therapy’s effectiveness has not been established in patients who have tried and failed to receive benefit from at least two or more prior antidepressant medications at minimal dose and duration; nor has it has been studied in patients without prior antidepressant medication treatment
Studies are being released every year which show that TMS could be used to alleviate symptoms stemming from Parkinson’s Disease, Fibromyalgia, and even Multiple Sclerosis. TMS has even been shown to reverse the effects of OCD, PTSD, and especially migraines. It may be some time before your doctor can prescribe TMS for these indications and before your insurance company will cover treatment, but clinical studies are being conducted nationwide and are always looking for participants.
*Please note that in early 2014, the FDA cleared a TMS device for treatment of Migraines accompanied by auras.
Because of the nature of magnetic energy and its reciprocal effects, patients with certain types of implants should not receive TMS Therapy. This includes pacemakers, implantable cardioverter defibrillators (ICDs) and vagus nerve stimulators (VNS).
In addition, TMS Therapy should not be administered to persons who have non-removable magnetic-sensitive metal in their head or other part of their body that would be within 12 inches of the TMS coil. Failure to follow this rule may cause the object to heat up, move, or malfunction, and result in serious injury or death. Persons with braces and/or metal dental fillings are acceptable for treatment.
Objects that may have incompatible metals may include:
Before the first TMS session, patients are carefully screened for the presence of medical conditions which include seizure disorder and epilepsy. The TMS prescribing psychiatrist or doctor should discuss any underlying risk factors that could make the administration of TMS Therapy unsafe. If you have any concerns about the risk of seizure or any other side effect it is highly recommended that you consult with your doctor before starting TMS Therapy.
The causes of depression have been linked to abnormal function of nerve cells in specific parts of the brain. As a result, these regions of the brain are implicated in mood regulation. In treating major Depressive Disorder, it is believed that the electromagnetic currents from the TMS coil activate specific neurotransmitters — serotonin, norepinephrine and dopamine — which have been implicated in the symptoms of depression. It is thought that TMS Therapy stimulates regions that are thought to be impaired by the patient’s condition. For Major Depression, the treatment coil is applied to the head above the left prefrontal cortex. It does not affect the whole brain. TMS only reaches about two to three centimeters into the brain directly beneath the treatment coil. Targeting these specific regions of the brain reactivates the neurons in those areas by depolarizing them. Current research suggests that when small electrical currents are directed at the prefrontal cortex of the brain, there is an increase blood flow and glucose metabolism, which may elevate mood. This has been documented in neuroimaging studies which have directly observed changes in cortical metabolic activity in tissue directly stimulated by TMS Therapy.
TMS Therapy utilizes a TMS coil which is either applied to the scalp or waved over the prefrontal cortex by a trained TMS technician. This TMS coil is designed to deliver highly focused magnetic pulses to the left prefrontal cortex. The TMS coil stimulation in the part of the brain that regulates mood is believed to trigger a cascade of neurochemical events, including the release of neurotransmitters (such as serotonin, norepinephrine, and dopamine) to help normalize neurotransmitter function.
The highly concentrated electromagnetic fields created by the magnetic coil turn on and off very rapidly. These magnetic fields are similar to those produced by a magnetic resonance imaging (MRI) machine. Although they are small, these induced electric currents in the brain can cause the neurons to fire or become more active. It is this stimulation which is believed to trigger further changes in the brain circuits responsible for depression. In other words, the magnetic pulses delivered from the TMS coil reinvigorate parts of the brain that might not be working properly in severely depressed patients.
The TMS Machines that are currently approved for use in the United States are Neurostar TMS Therapy & Brainsway.
Neuronetics pioneered clinical TMS practice in the United States. They played a pivotal role in educating the public and clinicians on TMS and advocating for insurance coverage in several states. The NeuroStar TMS Therapy system is also the first TMS device to have been evaluated in a large, multicenter, controlled clinical trial, as well as the only TMS system with the durability of its effects over 12 months established. With nearly 500 NeuroStar physicians providing therapy, and more than 12,000 patients treated, this novel treatment approach to achieving remission is bringing new hope to patients every day.
In an independent, randomized, controlled trial funded by the National Institute of Mental Health, 307 patients were treated with the NeuroStar TMS System for 4 to 6 weeks, similar to real clinical context.
Patients were divided into two groups:
At the end of their treatments, patients who had received NeuroStar TMS Therapy were four times more likely to achieve remission compared to patients receiving a sham treatment. 1 in 2 patients experienced significant improvement in their depression symptoms and 1 in 3 experienced complete remission. Patients treated with the NeuroStar TMS System also experienced significant improvement in anxiety and physical symptoms (such as appetite changes, aches and pains, and lack of energy) associated with depression.
By the end of the 12-month period, 2 out of 3 patients who had either responded or completely remitted after TMS treatment remained at the symptom levels they reported at the end of the treatment phase. After the end of the treatment period, only 1 in 3 patients needed to come back for maintenance TMS sessions, or 'reintroduction' during this 12-month period.
Brainsway's Deep TMS is FDA was cleared in January 2013 for treating depressive episodes in adult patients suffering from Major Depressive Disorder who failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode.
Brainsway's Transcranial Magnetic Stimulation technology is based on patents filed by the U.S. National Institutes of Health (NIH), and by the company. The company holds an exclusive license from the NIH for the patent and for Deep TMS technology.
Brainsway runs clinical research programs with leading scientists worldwide, collaborating with prominent institutions and researchers in clinical trials covering various neuropsychiatric and neuroscience applications.
The company's Transcranial Magnetic Stimulation technology has already been applied in thousands of cases worldwide in the framework of clinical studies. It has also been enthusiastically embraced by leading research institutions worldwide, with over 60 clinical trials held across the globe.