Deep Transcranial Magnetic Stimulation (Deep TMS) is an innovative treatment currently FDA-cleared for treatment-resistant major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and smoking addiction. Transcranial magnetic stimulation (TMS) is applied by resting a coil on the patient’s head. An electrical current flows through the coil, generating a magnetic field that penetrates through the skull and induces a second electrical flow of current in the brain. When finding the patient’s motor threshold (MT), as the current flows through the coil the patient will experience involuntary activation of different muscle groups depending on the positioning of the coil over the motor cortex.
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TMS is prescribed and directly supervised by healthcare providers who are trained in TMS, as well as numerous other treatment modalities. TMS is administered by trained technicians who are familiar with different TMS protocols but may only administer exactly what is prescribed. They are trained to handle an adverse event, such as a seizure. Provider supervision takes place in several ways: (1) initial diagnosis and treatment planning, (2) treatment progress is monitored through patient rating scales and follow-up appointments, (3) if necessary, the TMS operator can call the provider to answer a question and have the provider observe treatment in-person or via video, (4) if there is uncertainty about whether to continue TMS or change the protocol, this should be discussed with the provider, not the technician.
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I understand that I must make staff aware of any metal implants or objects in my body, specifically in my head and neck. I understand that the only contraindication for TMS is metal implants or implantable devices in or around the head. I understand that failure to notify staff of metal implants or implantable devices could result in serious injury or death.
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I understand there are alternative treatment options for my condition, including medications, psychotherapy and ECT. My doctor has explained or will explain at my consultation the risks and benefits of these other options as well as TMS. My doctor has also explained or will explain to me at my consultation, why TMS may be recommended for my specific case and answer any questions that I have.
TMS Potential Risks and Discomforts:
TMS has been used since 1985 and has been FDA-cleared for depression since 2008. Several adverse effects may occur from TMS treatment:
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Patients may experience headaches, face pain, jaw pain, tooth pain, or neck pain. In most cases, over-the-counter medication (e.g. ibuprofen, acetaminophen, aspirin) will relieve the pain. The vast majority of patients find TMS to be tolerable.
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TMS produces a loud clicking noise during stimulation, which can result in tinnitus or hearing loss if ear protection is not used. To prevent risk, earplugs are provided. The risk of hearing loss when wearing earplugs is most likely less than 0.01%, or 1 in 10,000 patients.
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TMS can induce a seizure, even in the absence of brain lesions, epilepsy, or other risk factors. The overall risk for seizures during Deep TMS has been extensively studied and is approximately 0.06% or 6 in 10,000 patients. TMS does not cause epilepsy.
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TMS could potentially cause inadvertent teeth clenching, biting of the tongue, and chipping teeth. The overall risk for this is very low.
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TMS could theoretically induce transient changes in cognition or movement. However, safety studies across numerous clinical trials have found no such side effects to-date.
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Risks of exposure to a magnetic field during pregnancy are not fully understood.
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There is only one absolute contraindication for Deep TMS – the presence of a ferromagnetic (highly susceptible to magnetization) substance in the head.
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While TMS effectiveness and safety has been studied for up to a year, the long-term effects of TMS are unknown.
I understand that TMS produces a loud clicking noise with each pulse. I understand I must wear earplugs at each session to minimize the risk of hearing loss. I understand there have been no reported cases of permanent hearing loss with TMS. If I experience hearing loss of any kind, I will alert staff immediately.
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I understand that if I have a diagnosed or undiagnosed Bipolar diagnosis, there is a slight risk for the emergence of mania with TMS. My doctor has informed me of this. If I experience mania, I will alert the staff immediately.
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I understand that I will inform the staff if there are any changes to my medications, alcohol use, sleep or if I am experiencing suicidal ideations before each treatment.
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I understand that TMS is not effective for all patients and my depressive symptoms may not improve or may get worse.
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It’s normal for those undergoing TMS to experience a worsening of symptoms before the potential for feeling better.
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I understand that the risk of exposure to TMS in pregnancy is unknown and will alert staff if I am or think I will become pregnant.
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I understand there are no known long-term risks associated with TMS.
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I understand that in accordance with Ohio Law, written requests must be signed for the release of medical records.
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I understand that for the safety and protection of patients and staff, our office is monitored by video recording including clinician offices and treatment rooms.
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I understand that I may revoke the consent for treatment both verbally and in writing by emailing: info@optimumtms.com or send a letter to our office.
I acknowledge that I have read and understood this information and consent to treatment for my condition and as provided by Mark E. Blair, MD, ABPN Board Certified Psychiatrist and qualified staff at Metro Psychiatry/ Optimum TMS