Deep Brain Stimulation (DBS) of the Globus pallidus (GP) in Huntington's disease (HD): A prospective, randomized, controlled, multi-centre study

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There is high level of evidence for deep brain stimulation (DBS) for successful symptomatic treatment of other movement disorders but only a few case reports of DBS in Huntington´s Disease (HD). Thus, DBS was evaluated in a prospective pilot trial for the symptomatic treatment of HD. Based on our pilot trial results there is evidence, that DBS of the pallidum significantly improves especially choreatic symptoms in HD. It also has positive influence on total UHDRS. Therefore this prospective multi-centre trial aims at proving the short and long-term efficacy and safety of pallidal DBS in 44 HD patients in a sham-stimulation controlled design. The study focuses on potential influence on Quality of life (QOL) and motoric improvement. Primary endpoint will be the UHDRS change from baseline to 12 weeks postoperatively (control group off stimulation vs. verum group on stimulation). Furthermore there will be a battery of motor scores, quantitative motor measurements, cognitive and psychiatric evaluations and questionnaires for QOL at 12 weeks postoperatively. Long-term effects on these scores will be evaluated in the following unblinded 3 months phase (secondary endpoint 6 months postoperatively). An open follow-up up to 12 months will be assessed for UHDRS and side effects (AE). The planned clinical trial furthermore opens perspective for additional funded neurophysiological studies to explore mechanisms of deep brain stimulation in patients with HD.