Double Blind Comparison of Optimised Deep Brain Stimulation for Severe Tourette Syndrome
Op-TICS is a clinical investigation of the use of Deep Brain Stimulation (DBS), with a CE marked implantable device, to reduce severe motor and vocal tics in patients who suffer from Tourette Syndrome (TS). It is a randomised, double-blind, crossover clinical investigation for 20 patients. Op-TICS will be performed at the National Hospital for Neurology \& Neurosurgery. Following DBS surgery, participants will first enter an open adjustment phase, of 6 months, where the electrical stimulation settings of the device are optimised. Participants will then enter the double-blind phase that will include successively up to 2 weeks with stimulation on and up to 2 weeks with the stimulation off in a randomised order. The primary outcome measure is the tic severity score measured by the Yale Global Tic Severity Scale -Total Tic Score after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase
⁃ Adult patients aged 18 and over:
• with chronic, severe, treatment refractory Tourette Syndrome, as defined by a Yale Global Tic Severity Scale score (YGTSS (global)) \>50/100
• with failure to respond to a minimum of two antipsychotic drugs prescribed separately at maximally tolerated doses for a minimum of 6 weeks OR, intolerance of these medications causing early cessation due to adverse events
• who have provided agreement to participate and written informed consent