The EXCITE Trial

Abstract

Marc Fisher MD Kennedy Lees MD Section Editors: Much of the attention in the field of stroke is focused on prevention, emergency response, and management of the acute inpatient stay. Despite these efforts, many patients are left with substantial disability. Patients survive their stroke for a mean of 8 years, making poststroke disability a highly prevalent condition; most of the days during which stroke affects the life of the patient occur in this chronic disability phase. Increased attention is being paid to an emerging set of therapeutic targets that are related to repair and restoration. Such restorative therapies focus on improving function in surviving brain areas rather than salvaging acutely threatened tissue and therefore might be available to a high proportion of patients with stroke. Animal studies have suggested a wide range of potential restorative therapies, including interventions based on physical, cellular, pharmacological, and electromagnetic approaches. However, to date, there has been limited translation of these preclinical findings into late-phase human clinical trials. In this regard, the Extremity Constraint Induced Therapy Evaluation (EXCITE) trial1 is a major step forward. It is unique among trials of restorative interventions for its size, meticulous multisite organization, preparation,2 duration of follow up, derivation from biological principle, and application of clinical trial methodology. In many ways, the EXCITE trial represents a paradigmatic shift in restorative stroke trials. The EXCITE trial was a prospective, single-blind, randomized, multisite clinical study conducted at 7 US academic institutions between 2001 and 2003. The study randomized a total of 222 patients with a first ischemic or …