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Preparing for DTMS 

WHAT IS dTMS?

dTMS is a non-invasive FDA-cleared medical procedure for the treatment of Major Depressive Disorder in adults. DTMS Treatment is a safe and effective treatment for patients with depression or OCD who have not benefitted from antidepressant or psychotropic medications.

dTMS is a brain stimulation technique that relies on the generation of brief magnetic fields using an insulated coil that is placed over the scalp. These magnetic fields are the same type and strength as those used in magnetic resonance imaging (MRI) machines. The magnetic pulses generate a weak electrical current in the pre-frontal cortex region of the brain that briefly activates neural circuits at the stimulation site. dTMS has been shown to be a safe and well-tolerated procedure that can be an effective treatment for adult patients with depression who have not benefitted from anti-depressant medications.

The potential benefit of Brainsway’s unique, patented technology is that it may lead to improvements in the symptoms of my psychiatric condition. I understand that not all patients respond equally well to dTMS. Like all forms of medical treatment, some patients recover quickly, others recover briefly and later relapse, while others may fail to have any response to dTMS.

Studies have shown the treatment to be effective for patients with MDD who have failed to respond to or couldn’t tolerate medication. In real-life clinical settings, the treatment was proven to be effective for 3 out of 4 patients, with a 51% remission rate and a 75% response rate. BrainsWay’s unique treatment and personalized protocol can provide relief for your depression symptoms.

 

ALTERNATIVES TO dTMS

I understand that there are alternative treatment options for my condition, including medications, psychotherapy, and electroconvulsive therapy (ECT). My doctor has explained to me the risks and benefits of these other options. My doctor has also explained why dTMS has been recommended for my specific case.

dTMS Treatment has been shown to be a safe and effective treatment for patients with certain mental disorders who have not benefitted from medication or other traditional treatments. The U.S. Food and Drug Administration (the “FDA”) has permitted use of dTMS as a treatment for major depressive disorder and obsessive-compulsive disorder.

While the FDA may not have specifically approved the use of the dTMS system for other disorders, healthcare providers are permitted to use the treatment for an “unapproved” or “off-label” use when the provider considers such treatment is medically appropriate for the patient.

 

SAFETY & RISK INFORMATION

The safety of the Brainsway dTMS system was demonstrated in a clinical study involving 233 patients with moderate to severe Major Depressive Disorder. However, as with any other medical procedures and forms of treatment, Brainsway dTMS involves some risks and side effects. During the treatment, I may experience tapping, facial twitching, or painful sensations at the treatment site while the magnetic coil is turned on. These types of sensations are reported in about one third of patients. I understand that I should inform staff if this occurs.

The treatment staff may then adjust the stimulation settings or make changes to where the coil is placed in order to help make the procedure more comfortable for me. In addition, about half of patients experience headaches. Headaches were reported in 47% of the subjects participating in the clinical study. However, 36% of patients who had received a placebo treatment instead of dTMS also reported headaches, indicating that the headaches were not necessarily caused by the dTMS treatment. Application site pain and discomfort was reported in 25% and 20%, respectively, of those subjects participating in the clinical study. I understand that I should inform the dTMS technicians and my doctor if this occurs. The dTMS helmet may be slightly adjusted on the head to relieve the pain or discomfort. Pain and discomfort associated with treatment usually gets better or goes away altogether with successive treatments.

The most serious known risk of dTMS is the production of a seizure. Although there have been a few case reports of seizures with the use of DTMS devices, the risk is extremely small. There was one case of seizure reported in Brainsway’s FDA clinical study due to high alcohol consumption the night before, and three other cases of seizure were reported in other studies (out of approximately 50,000 treatment sessions) in cases of subjects who were on high doses of antidepressants. None of the subjects who have experienced seizure during dTMS treatment have suffered lasting physical sequelae. I understand that I must discuss with my doctor if I have consumed or intend to consume alcohol/drugs prior to treatment. I understand that I must discuss with my doctor if I have a history or family history of seizure/epilepsy or potential alteration in seizure threshold. This includes stroke, head/brain injury, change in medication, change in electrolyte balance, high intracranial pressure, severe headaches, presence of other neurologic disease(s) that may be associated with an altered seizure threshold, concurrent medication or other drugs that are known to lower the seizure threshold, secondary conditions that may significantly alter electrolyte balance or lower seizure threshold, or where a quantifiable motor threshold cannot be accurately determined.

Other side effects which may occur include possible hearing loss, pain in jaw, muscle twitching, anxiety, insomnia, retinal detachment, hypomania, and mania. I understand that I should inform my doctor if I experience any of these adverse events.

There are no known adverse cognitive (thinking and memory) effects associated with dTMS. There are no known long-term adverse effects reported with the use of dTMS.

However, as this is a relatively new treatment, there may be unforseen risks in the longterm that are currently unknown.

 

METAL IMPLANTS

dTMS should not be used by anyone who has non-removable magnetic-sensitive metal in their head or within twelve inches of the magnetic coil, with the exception of standard amalgam dental fillings. I understand that failure to follow restrictions could result in serious injury or death. Examples of restricted metal substances/objects include:

 Aneurysm clips or coils

 Stents in your neck or brain

 Implanted stimulators

 Cardiac pacemakers or implantable cardioverter defibrillator (ICD)

 Electrodes to monitor your brain activity

 Ear/eye ferromagnetic implants

 Metal ink in facial/head tattoos and permanent makeup

 Shrapnel or bullet fragments

 

 

There were no deaths in patients who took part in the clinical trial for Brainsway dTMS.

PROCEDURE

  1. dTMS involves a series of treatments. For each dTMS session, I will be brought to a room, comfortably seated on a chair, and a cushioned helmet will be placed over my head. Before the beginning of the dTMS procedure, I will be asked to remove any metal or magnetic sensitive objects (e.g. jewelry, glasses, credit cards etc.). Because the DTMS Treatment 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 for my comfort and safety. DTMS does not require anesthesia or sedation, so I will be awake and alert during the entire procedure.
  2. The insulated magnetic coil gently placed over my head will be adjusted by staff / technician by delivering a series of pulses until it gives just enough energy so that my 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. This threshold could fluctuate depending on a variety of factors. How often my motor threshold will be re-evaluated will be determined by my doctor.

 

  1. During the procedure, I will hear a clicking sound and feel a tapping sensation on my scalp. Once my motor threshold is determined, the helmet containing magnetic coil will be moved over a region of the brain that scientists think may be responsible for causing depression. I will receive a treatment as a series of “pulses” that lasts about two seconds, with a “rest” period of about 20 seconds between each pulse series. Treatment sessions typically last twenty to thirty minutes.

 

  1.  DTMS treatment session is conducted using a device called the dTMS Treatment 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. There is also a cooling system with the machine to cool the coil in case they get hot.

 

  1. Specifically, DTMS Treatment 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.

f.     During a DTMS treatment session, the doctor or a member of their staff will place the magnetic helmet on my head after wearing appropriate size cap. 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.

g.    Next, once motor threshold is determined, and I will receive the treatment as a series of “pulses”, with a “rest” period of about 20 seconds between each series. Treatment is to the left front side of my head and will take about 20-45 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 initially receive these treatments 5 times a week for 4 weeks (20 treatments) and I understand that additional treatments may be required in order to achieve maximum response. The treatment is designed to relieve my current symptoms of depression or OCD.

h.    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 the 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 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 DTMS Treatment System should not be used by anyone who has magnetic-sensitive metal in

their head or within 12 inches of the 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 ears or eyes

•             Bullet fragments

•             Other metal devices or objects implanted in the head.

 Seizures (sometimes called convulsions or fits) have been reported with the use of dDTMS devices.

 I understand that I may discontinue treatment at any time.

 

 

 

 

Safety and Risk Information

What is dTMS