Multicentric double-blinded crossover randomized clinical trial of deep brain stimulation for intractable Tourette syndrome

INTERVENTION: A stereotactic operation is performed aided by functional software and computed tomography (CT) or magnetic resonance imaging (MRI). Two permanent quadripolar leads (model 3387, Medtronic) are implanted bilaterally under general anesthesia. The pulse generators (Soletra, Medtronic) are also implanted bilaterally and attached to lead extensions at the same time. The pulse generator is activated and neuroelectrical parameters were changed by an investigator. Patients are randomized 1 month after DBS, and stimulation 'on' or 'off' is started in a double‐blinded fashion 1 month more later. Group A: 'On' for 3 months and 'off' for 3 months, then open‐labeled 'on' for 6 months. Group B: 'Off' for 3 months and 'on' for 3 months, then open‐labeled 'on' for 6 months. CONDITION: Intractable Tourette syndrome PRIMARY OUTCOME: Yale Global Tic Severity Scale (YGTSS) tic score SECONDARY OUTCOME: modified Rush Video‐Based Rating Scale (mRVRS); YGTSS social impairment score; Yale‐Brown Obsessive Compulsive Scale (Y‐BOCS) score; Short Form‐36 (SF‐36); Gilles de la Tourette syndrome‐specific health‐related ‐QOL scale (GTS‐QOL) INCLUSION CRITERIA: Inclusion criteria are a diagnosis of TS as defined in the articles of the Tourette Syndrome Classification Study Group and in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revised (DSM‐IV‐TR), an age of 18 years or older, a Yale Global Tic Severity Scale17 (TGTSS) total tic severity score of 35/50 or more, an inadequate response to at least two dopamine receptor antagonists and other agents such as serotonergic drugs, antiepileptic drugs, and benzodiazepines, and inadequate response to any psychotherapy.