I hereby consent to treatment with repetitive Transcranial Magnetic Stimulation (TMS) at Positive Beginnings.
I fully understand the following:
A. Purpose: The purpose of this procedure is to treat depression, especially depression that has not responded to medications. This procedure involves the passage of a magnetic field, induced by passing an electrical current through a coil of wire, affecting the brain in a specific area or areas of the brain to relieve depression. I am being offered this treatment because I have been diagnosed with depression which may likely respond to this treatment and that has not responded to treatment by other means, especially medication treatment. This procedure has been cleared by the United States Food and Drug Administration (FDA).
B. Procedures: I will be treated with a magnetic stimulator five days a week for four to six weeks initially and, depending upon my response to treatment, with further treatment at intervals deemed necessary by a doctor at Positive Beginnings. A doctor/physician will treat me at the first session, which will determine my ‘motor threshold’. Following the determination of the motor threshold, further treatments will be administered by a TMS technician. The treatment will be done under the supervision of a Physician, who may not be physically present at all times, but will be available for me and the TMS technician for consultation whenever TMS is being administered.
C. Exclusions: A history of seizures, major head trauma, metal objects implanted in the head (except dental fillings), or a brain lesion or abnormality, pacemaker, an implanted medication pump, a metal plate in my skull, or other problems precluding treatment as deemed appropriate by the treating physician.
I or my guardian am solely responsible for informing my doctor directly if there is any condition that may exclude me from this treatment, including all those listed above and any other condition of which I may reasonably have a concern. Not everyone responds to this treatment positively, and I understand that if my condition worsens during the course of treatment in any way, I am responsible for informing the technician or doctor of such worsening and bear full responsibility for failure to inform the treating doctor or his assistants of such change in my condition and its ultimate outcome. If my condition worsens to a degree beyond which my doctor feels treatment can no longer be provided, I will accept his decision as final and will indemnify him and hold him harmless for any consequences of such a decision.
For Women Only: The risk of exposure to TMS and pregnancy are unknown. If you are a woman of childbearing age and capacity, you may be asked to take a pregnancy test before starting treatment.
D. Possible discomfort and/or risks: I understand that I have a small risk of having a seizure during TMS. If I have a seizure as a result of this treatment, I agree to be transported to the nearest hospital emergency room if needed and to assume all financial and other costs of evaluation and treatment at such facility. The possibility of any long-term effects is unknown. Possible side effects or unpleasant effects of TMS are generally few, but may include and are not limited to: headaches, muscle jerks or twitches, pain, unusual sensory experiences, and muscle aches or tenderness, hearing loss, and others. Although none have been reported, the possibility of long term effects is not known. I understand that the explanation I have received may not be exhaustive or all-inclusive and that other more remote risks may be involved. I agree to hold Positive Beginnings, and all its principles, employees, heirs, and other persons not responsible for any of these listed or unpredictable risks or events.
E. Possible benefits: While the purpose of this treatment is to improve my depression, no guarantees have been given to me to that effect. If mood improvement occurs, I have received no guarantee that it will last for any specific period of time. I understand that I may be required to take medications even after the completion of treatment to prevent relapse.
F: Indemnification: I agree to hold Positive Beginnings, its partners, all independent contractors, employees, and staff, severally, harmless for any untoward event that is or was caused by an inherent risk of the procedure I willingly submit to and pursue. I do hereby willingly give up all legal remedies for any untoward event which may happen to me as a result of my treatment with TMS and agree that I will not attempt to sue any of the parties referenced herein.
G. Compensation: I understand that Positive Beginnings may be compensated for services by my insurance company or myself, jointly or separately. I will endeavor to satisfy all requirements of the insurance company in order to fully participate in their program of reimbursement, including the provision of photocopied documents to verify treatment. If my expenses for this treatment are not paid by my insurance company, I do hereby freely and willfully obligate myself to pay professional fees to Positive Beginnings in advance of the treatment by mutual agreement. My failure to do so will result in the cancellation of my treatment and continued illness, and I will hold Positive Beginnings harmless for such a result.
H. Withdrawal of Consent : I understand that I am free to change my mind and withhold my consent for treatment at any time without prejudice towards my condition or self. I understand that Positive Beginnings is free to discontinue any treatment at his discretion and will hold them harmless for so doing.
I. Acknowledgment of completeness of this document: I warrant that this document, in and of itself, is entirely sufficient for me to give my consent for the proposed treatment and shall constitute a complete and sufficient consent by myself and my heirs to carry out all the provisions of this document.