WHAT IS TMS?
TMS stands for transcranial magnetic stimulation. It is used to treat depression by stimulating the brain non-invasively using an electromagnetic field, similar to those magnetic fields produced by an MRI machine. During TMS Therapy, a magnetic field is administered in very short pulses to the part of your brain that research has demonstrated to be associated with depression. The typical initial outpatient course of treatment is about 30-60 minutes over a 4-6 week period.
HOW DOES TMS WORK?
TMS Therapy system uses short pulses of magnetic fields to stimulate the pre-frontal cortex, the area of the brain that is thought to control mood. The magnetic field produces an electric current in the brain that stimulates the brain cells (neurons). This results in changes in the brain that are thought to be beneficial in the treatment of depression. Also, depending on the treatment parameters used, neuronal activity can be stimulated or inhibited. TMS is being used to reduce anxiety, hallucinations, and symptoms of PTSD by reducing brain activity in certain areas.
IS TMS A GOOD ALTERNATIVE FOR PATIENTS WHO CANNOT TOLERATE THE SIDE EFFECTS ASSOCIATED WITH ANTIDEPRESSANT MEDICATIONS?
TMS therapy is non-systemic (does not circulate in the blood throughout the body), so it does not have side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, among others that are commonly found with antidepressant drugs. The most common side effects reported with TMS during clinical trials were headache and scalp pain or discomfort – generally mild to moderate – occurring less frequently after the first week of treatment. TMS Therapy may not work for all patients with depression. You should speak with your doctor to determine if TMS Therapy is an appropriate treatment option for you.
Pregnancy: Many women choose to avoid antidepressant medications during pregnancy, but Depression itself has been shown to cause complications. Based on a number of studies, TMS appears to be a promising treatment option for pregnant women who do not wish to take
IS TMS LIKE OTHER ALTERNATIVE THERAPIES WHICH USE MAGNETS TO TREAT SOME ILLNESSES?
No. TMS Therapy involves a unique method of using pulsed magnetic fields for therapeutic benefit. The intensity of the magnetic field is similar to that of the magnetic fields used in magnetic resonance imaging, or MRI. These techniques differ radically from the use of low intensity, static magnetic fields. These products deliver weak and undirected static fields that are not capable of activating brain cells.
IS TMS LIKE ELECTROCONVULSIVE THERAPY (ECT)?
No, the two procedures are very different. While both are effective in the treatment of depression, there are many differences in safety and tolerability.
During the TMS Therapy procedure, patients sit in a chair and are awake and alert throughout the entire 37-minute procedure – no sedation is used with TMS Therapy. Patients can transport themselves to and from treatment.
In over 10,000 active treatments with TMS Therapy in clinical trials, no seizures were observed. However, post-marketing surveillance has shown there may be a remote risk of seizure with TMS Therapy. TMS Therapy was consistently shown to have no negative effects on memory function in clinical studies.
In contrast, electroconvulsive therapy (ECT), intentionally causes a seizure. Patients receiving ECT must be sedated with general anesthesia and paralyzed with muscle relaxants. Recovery from an ECT treatment session may be rapid over several minutes, or take a few hours. Patients are not allowed to drive immediately after having ECT.
Short-term confusion and memory loss are common with ECT, and long-term disruptions in memory have been shown to occur in some people. Because of the side effects associated with ECT, a significant amount of caregiver support may be required.
WHAT IS A TYPICAL COURSE OF TREATMENT WITH TMS?
In clinical trials, patients received TMS Therapy 5 times per week for 37 minutes sessions over 4-6 weeks.
Dr. Edward Fruitman customizes a treatment protocol according to each patients clinical needs. The frequency and duration of treatment is dependent on the initial consult and the patient’s specific needs. Patients treated with TMS Therapy typically receive treatment for a minimum of four weeks with additional treatments based on clinical judgment.
WHAT ARE THE POTENTIAL RISKS OF TMS?
TMS Therapy is well tolerated and has been proven to be safe in clinical trials. Throughout over 10,000 active treatments performed in clinical trials, the most commonly reported side effect related to treatment were scalp pain or discomfort during treatment sessions. These side effects were generally mild to moderate, and occurred less frequently after the first week of treatment. Less than 5% of patients treated with TMS Therapy discontinued treatment due to side effects.
In clinical trials, over 10,000 TMS treatments demonstrated its safety, with no occurrence of seizures. However, there is a small risk of a seizure occurring during treatment.
While TMS Therapy has been proven effective, not all patients will benefit from it. Patients should be carefully monitored for worsening symptoms, signs or symptoms of suicidal behavior, and/or unusual behavior. Families and caregivers should also be aware of the need to observe patients and notify their treatment provider if symptoms worsen.
WHO SHOULD NOT RECEIVE TMS?
TMS Therapy should not be used in patients with implanted metallic devices or non-removable metallic objects in or around the head. TMS Therapy should be used with caution in patients with implanted devices that are controlled by physiological signals. This includes pacemakers and implantable cardioverter defibrillators (ICDs). It should be used in caution with patients using wearable cardioverter defibrillators.
DOES TMS CAUSE BRAIN TUMORS?
No, TMS Therapy uses the same type and strength of magnetic fields as MRIs (magnetic resonance imaging), which have been used in tens of millions of patients around the world and have not been shown to cause tumors. The magnetic energy used in a full course of TMS Therapy is a small fraction of just one brain scan with an MRI.
DOES TMS CAUSE MEMORY LOSS?
No, TMS Therapy was systematically evaluated for its effects on memory. Clinical trials demonstrated that TMS Therapy does not result in any negative effects on memory or concentration.
IS TMS USED FOR OTHER NEUROPSYCHIATRIC DISORDERS BESIDES DEPRESSION?
Currently, TMS is used primarily for the treatment of Major Depressive Disorder, which is the only indication approved by the FDA. However, since TMS can be used to stimulate different regions of the brain in different ways, it is also used as a treatment for Bipolar Depression, Anxiety, Obsessive Compulsive Disorder, PTSD, Auditory Hallucinations associated with Schizophrenia, Negative symptoms associated with Schizophrenia, Migraine Headaches, Fibromyalgia, and Tinnitus. As you can see this is a very exciting and evolving technology.
ARE THERE SIDE EFFECTS OF TMS THERAPY?
Since TMS does not circulate through the body, it doesn’t cause any of the side effects that medications might have such as dry mouth, upset stomach, dizziness, drowsiness, weight gain, or sexual dysfunction. The most common side effect related to treatment is scalp pain or discomfort during treatment sessions. If necessary, you can treat this discomfort with an over-the-counter analgesic. If these side effects persist, your doctor can temporarily reduce the strength of the magnetic field pulses being administered in order to make treatment more comfortable.
IS TMS UNCOMFORTABLE?
The most common side effect related to treatment is scalp pain or discomfort during treatment sessions — generally mild to moderate.
If necessary, you can treat this discomfort with an over-the-counter analgesic. If these side effects persist, your doctor can temporarily reduce the strength of the magnetic field pulses being administered in order to make treatment more comfortable.
Less than 5% of patients treated with TMS Therapy discontinued treatment due to side effects.
HOW LONG DOES THE ANTIDEPRESSANT EFFECT LAST? WILL I NEED ANY THERAPY BEYOND THE FIRST 4-6 WEEKS?
In most patients, the clinical benefit of TMS Therapy was maintained through 12 months of follow-up study. Maintenance treatment is available if necessary. Talk to your doctor about your long-term treatment path.
CAN I ALSO TAKE ANTIDEPRESSANTS IF I AM RECEIVING TMS?
Yes. In clinical trials, TMS Therapy was safely administered with and without other antidepressant medications.
WHAT DOES FDA APPROVAL MEAN?
The NeuroStar TMS Therapy system is the first and only TMS device to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of Major Depressive Disorder. FDA approval was based on a large, multicenter, placebo-controlled trial for the treatment of Depression (O’Reardon. Biol Psychiatry, 2007). TMS devices are currently in use outside of the U.S. for psychiatric disorders, and within the U.S. for other indications such as spinal cord injuries.
OFF-LABEL APPLICATIONS OF TMS THERAPY
The term “off-label” refers to the absence of FDA clearance or approval for a device or medication. Pharmaceutical companies and device manufacturers are not allowed to promote a product for any other purpose then what was studied in the FDA trials. However, once a drug or device has been approved for sale for one purpose, physicians are free to prescribe it for any other purpose that in their professional judgment is both safe and effective, and are not limited to official, FDA-approved indications. There is growing research and clinical application regarding use of TMS targeting additional psychiatric and non-psychiatric disorders. TMS Therapeutics is on the cutting edge of new research in developing protocols to discover new applications in addition to expanding on currently known uses.
HOW LONG HAS TMS THERAPY BEEN USED AS A TREATMENT FOR DEPRESSION?
TMS was invented in 1985 and was originally used for research, and it has been used to treat depression since the late 1990s. In 2008, the FDA approved a new type of TMS device, known as the NeuroStar® TMS Therapy System, which is designed especially for the clinical treatment of depression.
HOW QUICKLY DOES TMS THERAPY WORK?
Depression is a syndrome that can have many different symptoms and not every person with depression has the same symptoms. Therefore responses to TMS vary from person to person. However, many people report thinking more clearly and improvements in sleep pattern, energy level, and appetite during the first week or two of treatment. Many times these symptoms improve before a person’s mood.
HOW EFFECTIVE IS TMS THERAPY AS A TREATMENT FOR DEPRESSION?
Clinical studies have shown that TMS is effective about 75% of the time, which means that it is twice as effective as antidepressant medications and almost as effective as electroconvulsive therapy (ECT). Half of those who respond to TMS experience significant improvement in the first four weeks of treatment.
IS TMS THERAPY A CURE FOR DEPRESSION?
Everyone’s depression is different, however 90% of patients who respond to TMS continue to do well a year after treatment. Some people may require periodic or “maintenance” TMS, which often consists of just one or two treatments every few weeks or months. Some people also begin do well on medications, even if they did not help before TMS treatment, which helps maintain the long term therapeutic benefit of TMS Therapy.
HOW MUCH DOES TMS THERAPY COST?
A majority of insurance plan do not have an established coverage policy for TMS Therapy. As a result, out of pocket expenses may be necessary to receive treatment. Since the cost of treatment can vary based on a number of factors, including the total number of treatments, it is our policy not to quote specific costs. We offer a complimentary consultation in order to address each patient’s individual needs and discuss payment options. Please contact our office to inquire further about cost and financing.
IS THERE A CONSULTATION FEE?
No, our consultation is completely free and complementary. At the time of the consultation you will receive a comprehensive consultation with a complete mental health assessment, complex medical decision making and a detailed introduction to TMS Therapy, how it works, and how it may or may not benefit you. During the consultation the treatment protocol and out-of-pocket cost will be determined. We will also look into any potential insurance and reimbursement coverage.
IS TMS Covered by insurance?
No, a majority of insurance plan do not have an established coverage policy for TMS Therapy. Some insurance companies cover TMS based on medical necessity. If insurance has coverage availability for TMS Therapy we will investigate the benefits and initiate the coverage process on your behalf.