Dystonia clinical trials at UC Health
2 in progress, 1 open to new patients
open to eligible people ages 7-25
Dystonia is a movement disorder seen in both children and adults that is characterized by "sustained or intermittent muscle contractions causing abnormal, often repetitive, movements, postures, or both." Secondary dystonia is far more common in pediatric populations than primary dystonia, and far more recalcitrant to standard pharmacologic and surgical treatments including Deep Brain Stimulation (DBS). There exists a large unmet need to develop new therapeutics, treatment strategies, and outcome measures for pediatric secondary dystonia. The investigators are proposing to investigate the ventralis oralis posterior nucleus (Vop) of the thalamus as a new target for DBS in secondary dystonia. Prior to the development of DBS, the main surgical treatment of dystonia was thalamotomy. Although there were many different targets in the thalamus, often done in staged procedures, the most common and successful targeted nuclei was the Vop, which is traditionally thought to be the pallidal receiving area. Previous lesioning of Vop produced improvements in dystonia but intolerable side effects, especially when implanted bilaterally. However, given that secondary dystonia patients were often reported to have superior results to primary dystonia it is reasonable to believe that if the side effects can be modulated, that targeting of the Vop nucleus with DBS could be a viable alternative to Globus Pallidus interna (GPi). Given that Deep Brain Stimulation is a treatment that is inherently adjustable, it is conceivable that settings on the Deep Brain Stimulation could be adjusted to allow for clinical benefit with minimal side effects. Indeed, there have been several scattered successful case reports attesting to this possibility.
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This is an exploratory pilot study to test a variety of strategies for feedback-controlled deep brain stimulation. Twenty Parkinson's disease patients with motor fluctuations and will be implanted bilaterally with a totally internalized bidirectional neural interface, Medtronic Activa RC+S. Each RC+S will be attached to both quadripolar subthalamic DBS lead, and quadripolar subdural cortical paddle lead. Investigators will collect and characterize each subject's physiological biomarkers related to the hypokinetic and hyperkinetic state to prototype classifier/control algorithms both in vitro and during a brief in-clinic test in study subjects. There will be a small pilot clinical trial in which individualized classifier/control strategies for each hemisphere in each subject will be embedded within the RC+S for one month of feedback-controlled stimulation, to be compared with one month of empirically optimized open-loop stimulation, administered in randomized order with closed-loop stimulation.