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Randomized Controlled Trial
. 2021 May-Jun;14(3):662-675.
doi: 10.1016/j.brs.2021.04.004. Epub 2021 Apr 18.

Randomized double-blind sham-controlled trial of thalamic versus GPi stimulation in patients with severe medically refractory Gilles de la Tourette syndrome

K R Müller-Vahl  1 , N Szejko  2 , A Saryyeva  3 , C Schrader  4 , D Krueger  5 , A Horn  6 , A A Kühn  7 , J K Krauss  3
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Free article
Randomized Controlled Trial

Randomized double-blind sham-controlled trial of thalamic versus GPi stimulation in patients with severe medically refractory Gilles de la Tourette syndrome

K R Müller-Vahl et al. Brain Stimul. 2021 May-Jun.
Free article

Abstract

Background: There are still no sufficient data regarding the use of deep brain stimulation (DBS) in Gilles de la Tourette syndrome (GTS) and no agreement on optimal target.

Objective: To compare efficacy and safety of bilateral DBS of thalamus (centromedian-ventro-oral internus, CM-Voi) versus posteroventral lateral globus pallidus internus (pvl GPi)) versus sham stimulation, and baseline in severe medically refractory GTS.

Methods: In this randomized double-blind sham stimulation-controlled trial (RCT), 10 patients (3 women, mean age = 29.4 ± 10.2 SD, range 18-47) underwent three blinded periods each lasting three months including (i) sham, (ii) pvl GPi (on-GPi), and (iii) thalamic stimulation (on-thal) followed by an open uncontrolled long-term follow-up (up to 9 years) with individually determined target and stimulation settings.

Results: Nine patients completed the RCT. At group level, on-GPi - but not on-thal - resulted in a significant tic reduction compared to baseline, but had no effect on premonitory urges and psychiatric comorbidities. Direct comparisons of targets resulted in inconsistent or negative (compared to sham) findings. During follow-up, we found no improvement of tics, comorbidities, and quality of life at group level, however, single patients benefitted continuously from thalamic DBS. At last follow-up 89.9 months (mean) after surgery, 50% of patients had discontinued DBS. Hardware infections occurred in 3/10 patients.

Conclusion: Our data suggest that the initial effect of pvl GPi DBS is superior to thalamic (CM-Voi) DBS. While half of the patients discontinued treatment, single patients benefitted from thalamic DBS even after years. It is likely that outcome is influenced by various factors beyond the mere change in tic severity.

Keywords: Deep brain stimulation; Gilles de la Tourette syndrome; Randomized double-blind controlled trial; Thalamic stimulation; Tics; pvl GPi.

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Conflict of interest statement

Declaration of competing interest KMV has received financial or material research support from the EU (FP7-HEALTH-2011 No. 278367, FP7-PEOPLE-2012-ITN No. 316978), the German Research Foundation (DFG: GZ MU 1527/3-1), the German Ministry of Education and Research (BMBF: 01KG1421), the National Institute of Mental Health (NIMH), the Tourette Gesellschaft Deutschland e.V., the Else-Kroner-Fresenius-Stiftung, and GW, Abide Therapeutics, Lundbeck, Syneos Health, Therapix Biosciences Ltd, Almirall Hermal GmbH, GW pharmaceuticals; She has received consultant’s honoraria from Abide Therapeutics, Tilray, Resalo Vertrieb GmbH, Columbia Care, Bionorica Ethics GmbH, Lundbeck and Eurox Deutschland GmbH, speaker’s fees from Tilray, Wayland Group, Emalex, Eurox group, PR Berater, Aphria, Ever pharma GmbH, and Cogitando GmbH and royalties from Medizinisch Wissenschaftliche Verlagsgesellschaft Berlin Elsevier, and Kohlhammer. She holds shares of Nomovo Pharm. CS is consultant to AbbVie and received speaker’s fees from Abbvie, Merz, and Ipsen, and royalties from Elsevier. JKK is consultant to Medtronic and Boston Scientifc. Received fees for speaking from AbbVie and royalties from Cambridge University Press and Springer Verlag. AS received travel grants from Medtronic and research support from Boston Scientific. HHC received travel grants from Medtronic. NS, DK have no conflicts to declare. AAK is a consultant to Medtronic and Boston Scientific, she received speakers honoraria from Teva, Ipsen, Medtronic, Abbott and Boston Scientific. AH received financial support from the German Research Council (grant 410169619) and speaker honoraria from Boston Scientific and Medtronic.

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