Initial TMS Consent Form

Individualised Transcranial Magnetic Stimulation (TMS) is a non-invasive therapy using electromagnetic stimulation of the brain. The magnetic field produced by the procedure induces trace amounts of electrical current in the brain. It is used after diagnosis for treatment and has shown great promise in the treatment of certain conditions or disorders that are not responsive to conventional treatments. 

The procedure is administered by placing a special coil over the head while the patient remains seated in a chair. A powerful, painless, magnetic field is pulsed into the brain based on a specific treatment protocol. Each session takes approximately 30 minutes. Patients are thoroughly screened and evaluated before the treatment and are monitored during TMS treatment session by a trained and TMS technician or other certified clinician or practitioner to minimize any risk from the procedure, to monitor the patient’s response to treatment, and to monitor proper for continued treatment coil contact. 

There is no guarantee that patients will respond positively to this therapy and as with all therapies, there is a chance of injury. However, transcranial magnetic stimulation is Therapeutic Goods Agency (TGA)-approved for specific conditions, such as major depressive disorder in adult patients, and other conditions depending on the TMS system being used for treatment. The results of research and clinical trials have shown improvement and positive results in patients suffering from various neuropsychiatric disorders including anxiety, attention deficit disorder, autistic spectrum disorder, mild and moderate traumatic brain injury, substance abuse, and other psychiatric and neurological conditions. 

You are free to stop therapy at any time

SIDE EFFECTS: 

In certain circumstances seizures have been shown to occur. This average risk is believed to be 1 seizure per 50,0000-60,000 sessions in patients without seizure risk factors such as brain lesions or epilepsy (Rossi et al 2009, Lerner et al 2019)

About ten percent (10%) of patients undergoing this procedure will experience headaches and/or scalp discomfort at the treatment site that may last several hours following the treatment. Some patients may experience facial twitching, fatigue and lighheadedness. Some patients experience exacerbation or recurrence of previous symptoms during the early phase of treatment. Side effects generally subside after the first few treatment sessions. 

There is also small risk of inducing mania, particularly in those patients with a history of bipolar affective disorder.

I have been informed of the effects, anticipated length of time of treatment, frequency and duration of treatment, side effects, benefits and risks of the treatment listed above and give my consent voluntarily to participate in with TMS treatment as per the TMS information sheet. I acknowledge having read the TMS information sheets and have been provided with the opportunity to discuss this material with the Psychiatrist and TMS operator. 

I acknowledge that if I refuse ear protection, then this will be done at my own risk and treatment could be refused. 

I acknowledge there has been a discussion of risk benefit analysis in relation to my medical condition with respect to the aforementioned risks (including the low risk of seizures) and alternative treatments have been discussed.

I am aware of the initial treatment protocol, and that its parameters may change over the course of the treatment. 

If received Medicare rebated TMS, I declare that I am over 18 years old, have been diagnosed with a Major Depressive Episode, have not previously received TMS, have failed to receive satisfactory improvement for Major depressive episode despite the adequate trial of at least 2 different classes of antidepressant medication for at least 3 weeks.

I declare that the patient has been provided with the TMS information sheet and has been given a comprehensive explanation about TMS.

I declare that the patient has had adequate time to consider all factors related to their TMS treatment and has had adequate opportunity to discuss this with myself. This includes providing sufficient time for the patient to question myself and receive answers. 

I declare that the patient can weigh up these options and adequately communicate his or her decisions regarding TMS in a manner that is voluntary, consistent and without coercion. 

I declare that the patient demonstrates full capacity to make decisions regarding their participation in TMS treatment.