Patient Consent for TMS TherapyPatient Consent for TMS TherapyThis is a patient consent for a medical procedure called NeuroStar TMS Therapy. This consent form outlines the treatment that your doctor has prescribed for you, the risks of this treatment, the potential benefits of this treatment to you, and any alternative treatments that are available for you if you decide not to be treated with NeuroStar TMS Therapy. The information contained in this consent form is also described in the Depression Patient’s Manual for Transcranial Magnetic Stimulation with the NeuroStar TMS Therapy System which is available from your doctor. Not all information in the Manual is stated here, so you should read the Patient Manual and discuss any questions that you have with your doctor. Once you have reviewed the Manual and this consent form, be sure to ask your doctor any questions that you may have about NeuroStar TMS Therapy.ConsentBy initialing the following items, I agree that I understand the following:TMS Stands for “Transcranial Magnetic Stimulation.” NeuroStar TMS Therapy is a medical procedure. A TMS treatment session is conducted using a device called the NeuroStar TMS Therapy System, which provides electrical energy to a “treatment coil” or magnet that delivers pulsed magnetic fields. These magnetic fields are the same type and strength as those used in magnetic resonance imaging (MRI) machines.*NeuroStar TMS Therapy is a safe and effective treatment for patients with depression who have not benefited from antidepressant medications.*Specifically, NeuroStar TMS Therapy has been shown to relieve depression symptoms in adult patients who have been treated with one antidepressant medication given at a high enough dose and for a long enough period of time but did not get better.*At this time, there are no studies that show that NeuroStar TMS Therapy works for patients who did not get better after taking two or fewer antidepressant medications at a high enough dose and for a long enough period of time or who did not take any antidepressants during this current period of depression.*During a TMS treatment session, the doctor or a member of their staff will place the magnetic coil gently against my scalp on the left front region of my head. The magnetic fields that are produced by the magnetic coil are pointed at a region of the brain that scientists think may be responsible for causing depression.*To administer the treatment, the doctor or a member of their staff will first position my head in the head support system. Next, the magnetic coil will be placed on the left side of my head, and I will hear a clicking sound and feel a tapping sensation on my scalp. The doctor will then adjust the NeuroStar TMS Therapy system so that the devise will give just enough energy to send electromagnetic pulses into the brain so that my right hand twitches. The amount of energy required to make my hand twitch is called the “motor threshold.” Everyone has a different motor threshold and the treatments are given at an energy level that is just above my individual motor threshold. How often my motor threshold will be re-evaluated will be determined by my doctor.*Once motor threshold is determined, the magnetic coil will be moved, and I will receive the treatment as a series of “pulses” that last about 4 seconds, with a “rest” period of about 12 seconds between each series. Treatment is to the left front side of my head and will take about 20 minutes. I understand that this treatment does not involve any anesthesia or sedation and that I will remain awake and alert during the treatment. I will likely receive these treatments 5 times a week for 6 weeks (30 treatments) followed by 6 taper treatments over 3 weeks. I will be evaluated by the doctor each week during this treatment course. The treatment is designed to relieve my current symptoms of depression.*Once motor threshold is determined, the magnetic coil will be moved, and I will receive the treatment as a series of “pulses” that last about 4 seconds, with a “rest” period of about 12 seconds between each series. Treatment is to the left front side of my head and will take about 20 minutes. I understand that this treatment does not involve any anesthesia or sedation and that I will remain awake and alert during the treatment. I will likely receive these treatments 5 times a week for 6 weeks (30 treatments) followed by 6 taper treatments over 3 weeks. I will be evaluated by the doctor each week during this treatment course. The treatment is designed to relieve my current symptoms of depression.*During the treatment, I may experience tapping or painful sensations at the treatment site while the magnetic coil is turned on. These types of sensations were reported by about one third of the patients who participated in the research studies. I understand that I should inform he doctor or his/her staff if this occurs. The doctor may then adjust the dose or make changes to where the coil is placed in order to help make the procedure more comfortable for me. I also understand that headaches were reported in half of the patients who participated in the clinical trial for the NeuroStar device. I understand that both discomfort and headaches got better over time in the research studies and that I may take common over-the-counter pain medications such as acetaminophen if a headache occurs.*The following risks are also involved with this treatment. The NeuroStar TMS Therapy System should not be used by anyone who has magnetic-sensitive metal in their head or within 12 inches of the NeuroStar magnetic coil that cannot be removed. Failure to follow this restriction could result in serious injury or death. Objects that may have this kind of metal include:* Aneurysm clips or coils Stents Implanted Stimulators Electrodes to monitor your brain activity Ferromagnetic implants in your eyes or ears Bullet fragments Other metal devices or objects implanted in the headNeuroStar TMS Therapy is not effective for all patients with depression. Any signs or symptoms of worsening depression should be reported immediately to your doctor. You may want to ask a family member or caregiver to monitor your symptoms to help you spot any signs of worsening depression.*Seizures (sometimes called convulsions or fits) have been reported with the use of other types of TMS device; however, no seizures were observed with use of the NeuroStar TMS Therapy system in over 10,000 patient treatment sessions.*Because the NeuroStar TMS Therapy system produces a loud click with each magnetic pulse, I understand that I must wear earplugs or similar hearing protection devices with a rating of 30dB or higher of noise reduction during treatment.*I understand that most patients who benefit from NeuroStar TMS Therapy experience results by the fourth week of treatment. Some patients may experience results in less time while others may take longer.*I understand that I may discontinue treatment at any time.*I understand that not all insurance companies cover NeuroStar TMS Therapy and that it is my responsibility to contact my insurance regarding treatment benefits and if my insurance does not cover treatment or pay within a reasonable time; I will be responsible for the full payment.*I have read the Information contained in this Medical Procedure Consent Form about Neurostar TMS Therapy & its potential risks. I have discussed it with my doctor who has answered all of my questions. I understand there are other treatment options for my depression available to me and this has also been discussed with me. I therefore permit my doctor and his/her staff to administer this treatment to me.*Date* MM slash DD slash YYYY Name* First Last
