All treatments have potential risks. SigmaStim does not provide medical advice. SigmaStim only sells its products to licensed health providers and hospitals, and does not have direct interaction with Electroconvulsive Therapy (ECT) patients. Because SigmaStim does not have direct interaction with patients, this website and the Patients and Families Booklet are two of the only ways to provide patients with warnings about ECT.

SigmaStim's Patients and Families Booklet was cleared by the FDA, and the following warnings were stipulated by the FDA to include in the booklet:

Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated.

Warning: ECT device use may be associated with disorientation, confusion, and memory problems.

Warning: Patients treated with ECT may experience manic symptoms (including euphoria and/or irritability, impulsivity, racing thoughts, distractibility, grandiosity, increased activity, talkativeness, and decreased need for sleep) or a worsening of the psychiatric symptoms they are being treated for.

If you would like to read the entire Patients and Families booklet, it can be downloaded here: SigmaStim Patients and Families Booklet