Consent
The purpose of this informed consent and expectations is to ensure that communication between us (Bloom Healthcare) and you (the patient) are clear, consistent and understood.
TMS or Transcranial Magnetic stimulation is a non-invasive, FDA-cleared medical procedure for the treatment of Major Depressive Disorder in adults. Information about TMS has been/will be shared with me by the Doctor during my consultation and initial mapping.
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.
I understand 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 TMS has been recommended for my specific case.
The number of treatments I receive will depend on my psychiatric condition, my response to treatment, the medical judgment of my psychiatrist, and insurance authorization approval.
TMS treatments are usually administered five times per week and I will likely receive these treatments daily for four to six weeks. I may choose to end the treatments at any time.
I understand that TMS carries a risk of side effects. During treatment I may experience tapping, facial twitching or motor involvement.
I agree to alert staff if I experience these effects.
I understand that TMS may cause me to experience a headache but understand these are brief and limited.
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.
I understand 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 staff immediately.
I understand there is a risk of seizure associated with TMS. This risk is extremely small and has only been documented in a handful of cases. If I have had seizures in the past, I will notify staff. If I experience symptoms of a seizure during treatment, I will notify staff and emergency protocols will be initiated.
I understand that I will inform staff if there are any changes to my medications, alcohol use, sleep or if I am experiencing suicidal ideations before each treatment.
I understand that TMS is not effective for all patients and my depressive symptoms may not improve or get worse. It's normal for me to experience a dip in symptoms before the potential for feeling better.
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.
I understand there are no known long-term risks associated with TMS.
I understand that attendance is strongly encouraged and will make every effort to attend each of my scheduled appointments.
I understand that if I plan on missing an appointment, I will notify staff by phone or email.
I understand that if I am more than 15 minutes late, I may have to reschedule my appointment, depending on staffing, other treatments occurring or time of day.
I understand that I will be provided with a cost-estimate of the procedure via insurance benefits investigation. I understand I am responsible for any cost that is not covered by insurance.
I understand that in accordance with Pennsylvania Law, written requests must be signed for the release of medical records.
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.