Background, Significance and Preliminary Studies Sample Clauses

Background, Significance and Preliminary Studies. Movement disorder therapy has progressed significantly over the past decade. Pharmacologic therapies are established as the initial treatment for the vast majority of patients suffering from movement disorders. However, in severe cases, or where the disease progresses to a point where symptoms can no longer be adequately managed with medications, surgical intervention is increasingly being applied. Surgical interventions have undergone a transition from permanent lesioning of brain structures to the use of chronic stimulation electrodes whose effects are adjustable and reversible. Several structures within the thalamus and basal ganglia have been targeted, including the ventrolateral thalamus, dorsolateral sub-thalamic nucleus (STN), and posterior globus pallidus interna (GPI). The technology has primarily been applied to the treatment of Xxxxxxxxx’x disease (1) although other movement disorders including essential tremor (2) and dystonia (3) also appear to benefit from stimulation therapy. Additionally, DBS therapy has shown promise for an expanding list of applications including epilepsy (4), Tourette’s syndrome (5), obsessive compulsive disorders (6), depression (7), and traumatic brain injury (8). Magnetic resonance (MR) imaging plays a key role in the application and evaluation of these therapies. Specific deep brain structures can either be directly visualized with MR techniques, or can be inferred based on the location of surrounding structures. These capabilities make MR the modality of choice for pre-operative planning and post-operative assessment of electrode positioning. In this application, we propose to expand on our preliminary work aimed at using direct MR image guidance to place DBS electrodes within specific targets in the basal ganglia. Through our partnership with Surgi-Vision, Inc, we plan to create an optimized platform for precisely targeting deep brain structures. We will validate the methodology by assessing targeting accuracy in both phantoms and in two separate deep brain structures (STN and GPI). In order to assure that we are able to demonstrate clinical efficacy that is comparable to conventional implantation methodologies, we will evaluate clinical outcomes by measuring neurological and neuropsychological factors prior to and following DBS implantation. The technique has numerous potential advantages including more consistent electrode positioning, shorter surgeries, fewer brain penetrations and the ability to anesthetize pat...