Methodological issues in clinical trial design for TMS
This article explores the emergence of transcranial magnetic stimulation (TMS) as a new therapeutic approach and the implications of this technology for the study and treatment of neuropsychiatric disorders, with a focus on major depression. Relapse, chronicity, and varying degrees of treatment resistance characterize major depression. A substantial number of patients are not effectively treated with pharmacology or medications alone. It is proposed that TMS, along with other device-based therapies emerging in psychiatry, may define a potential new treatment platform, with existing therapeutics for major depression. Through the example of a study, this article describes the methodological considerations in the development of TMS for the treatment of major depression. Device-based approaches to therapeutic neuromodulation hold the promise of significant clinical advantages compared to existing treatments for major depression, but evidence in well designed and properly blinded multicenter trials is still lacking, hence, research in this area is ongoing.
