In this single-center trial, we aim to include 8 patients with severe and medically refractory Tourette's syndrome. All patients undergo deep brain stimulation surgery with two electrodes located in the centromedian-parafascicular complex. Tic severity and secondary outcome measurements are assessed six and twelve months after surgery. Additionally, a short randomized, double-blinded sham controlled crossover sequence of 24 to 48 hours in either active or sham stimulation is implemented after both 6 and 12 months assesments. Subjects and clinicians are blinded to treatment allocation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
University of Cologne
Cologne, Germany
Yale Global Tic Severity Scale (YGTSS)
Motor tic subscore range 0-25 Vocal tic scubscore range 0-25 Impairment range0-50 Total Score (Vocal tic score + Motor tic score + Impairment) range 0-100 Higher Scores indicate higher tic severity, thus worse outcome
Time frame: Change in the YGTSS Scale from Baseline to 6 and 12 months
Modified Rush video rating scale (MRVRS)
Range 0-20 Higher Scores indicate higher tic severity, thus worse outcome
Time frame: Change in the MRVRS Scale from Baseline to 6 and 12 months
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