Juan Carlos Baldermann1, Jens Kuhn2, Thomas Schüller3, Sina Kohl3, Pablo Andrade4, Sophia Schleyken5, Reinhild Prinz-Langenohl6, Martin Hellmich7, Michael T Barbe8, Lars Timmermann9, Veerle Visser-Vandewalle4, Daniel Huys3. 1. University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Cologne, Germany; University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Psychiatry and Psychotherapy, Cologne, Germany. Electronic address: juan.baldermann@uk-koeln.de. 2. University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Psychiatry and Psychotherapy, Cologne, Germany; Department of Psychiatry, Psychotherapy, and Psychosomatics, Johanniter Hospital Oberhausen, Oberhausen, Germany. 3. University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Psychiatry and Psychotherapy, Cologne, Germany. 4. University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Functional Neurosurgery and Stereotaxy, Cologne, Germany. 5. University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Cologne, Germany; University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Psychiatry and Psychotherapy, Cologne, Germany. 6. University of Cologne, Faculty of Medicine and University Hospital Cologne, Clinical Trials Centre, Cologne, Germany. 7. University of Cologne, Faculty of Medicine and University Hospital Cologne, Institute of Medical Statistics and Computational Biology, Cologne, Germany. 8. University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Cologne, Germany. 9. University Hospital Giessen and Marburg, Department of Neurology, Campus Marburg, Marburg, Germany; Center for Mind, Brain and Behaviour, Marburg, Germany.
Abstract
BACKGROUND: There is still a lack of controlled studies to prove efficacy of thalamic deep brain stimulation for Tourette's Syndrome. OBJECTIVES: In this controlled trial, we investigated the course of tic severity, comorbidities and quality of life during thalamic stimulation and whether changes in tic severity can be assigned to ongoing compared to sham stimulation. METHODS: We included eight adult patients with medically refractory Tourette's syndrome. Bilateral electrodes were implanted in the centromedian-parafascicular-complex and the nucleus ventro-oralis internus. Tic severity, quality of life and comorbidities were assessed before surgery as well as six and twelve months after. Short randomized, double-blinded sham-controlled crossover sequences with either active or sham stimulation were implemented at both six- and twelve-months' assessments. The primary outcome measurement was the difference in the Yale Global Tic Severity Scale tic score between active and sham stimulation. Adverse events were systematically surveyed for all patients to evaluate safety. RESULTS: Active stimulation resulted in significantly higher tic reductions than sham stimulation (F = 79.5; p = 0.001). Overall quality of life and comorbidities improved significantly in the open-label-phase. Over the course of the trial two severe adverse events occurred that were resolved without sequelae. CONCLUSION: Our results provide evidence that thalamic stimulation is effective in improving tic severity and overall quality of life. Crucially, the reduction of tic severity was primarily driven by active stimulation. Further research may focus on improving stimulation protocols and refining patient selection to improve efficacy and safety of deep brain stimulation for Tourette's Syndrome.
RCT Entities:
BACKGROUND: There is still a lack of controlled studies to prove efficacy of thalamic deep brain stimulation for Tourette's Syndrome. OBJECTIVES: In this controlled trial, we investigated the course of tic severity, comorbidities and quality of life during thalamic stimulation and whether changes in tic severity can be assigned to ongoing compared to sham stimulation. METHODS: We included eight adult patients with medically refractory Tourette's syndrome. Bilateral electrodes were implanted in the centromedian-parafascicular-complex and the nucleus ventro-oralis internus. Tic severity, quality of life and comorbidities were assessed before surgery as well as six and twelve months after. Short randomized, double-blinded sham-controlled crossover sequences with either active or sham stimulation were implemented at both six- and twelve-months' assessments. The primary outcome measurement was the difference in the Yale Global Tic Severity Scale tic score between active and sham stimulation. Adverse events were systematically surveyed for all patients to evaluate safety. RESULTS: Active stimulation resulted in significantly higher tic reductions than sham stimulation (F = 79.5; p = 0.001). Overall quality of life and comorbidities improved significantly in the open-label-phase. Over the course of the trial two severe adverse events occurred that were resolved without sequelae. CONCLUSION: Our results provide evidence that thalamic stimulation is effective in improving tic severity and overall quality of life. Crucially, the reduction of tic severity was primarily driven by active stimulation. Further research may focus on improving stimulation protocols and refining patient selection to improve efficacy and safety of deep brain stimulation for Tourette's Syndrome.
Authors: Laura Wehmeyer; Thomas Schüller; Jana Kiess; Petra Heiden; Veerle Visser-Vandewalle; Juan Carlos Baldermann; Pablo Andrade Journal: Front Neurol Date: 2021-10-20 Impact factor: 4.086
Authors: Natalia Szejko; Yulia Worbe; Andreas Hartmann; Veerle Visser-Vandewalle; Linda Ackermans; Christos Ganos; Mauro Porta; Albert F G Leentjens; Jan-Hinnerk Mehrkens; Daniel Huys; Juan Carlos Baldermann; Jens Kuhn; Carine Karachi; Cécile Delorme; Thomas Foltynie; Andrea E Cavanna; Danielle Cath; Kirsten Müller-Vahl Journal: Eur Child Adolesc Psychiatry Date: 2021-10-04 Impact factor: 4.785