• Yasmine Emma Maria Dreissen, Joke M Dijk, Jeannette M Gelauff, Evelien Zoons, Daniël van Poppelen, Maria Fiorella Contarino, Rodi Zutt, Bart Post, Alexander G Munts, Johannes D Speelman, Danielle C Cath, Rob J de Haan, Johannes Htm Koelman, and Tijssen Marina A J MAJ 0000-0001-5783-571X Neurology, Universitair Medisch Centrum Groningen, Groningen, The Netherlands m.a.j.de.koning-tijssen@umcg..
• Neurology and Clinical Neurophysiology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands.
• J. Neurol. Neurosurg. Psychiatr. 2019 Nov 1; 90 (11): 1244-1250.

ObjectiveTo study the effect of botulinum neurotoxin (BoNT) treatment in jerky and tremulous functional movement disorders (FMD).MethodsPatients with invalidating, chronic (>1 year) symptoms were randomly assigned to two subsequent treatments with BoNT or placebo every 3 months with stratification according to symptom localisation. Improvement on the dichotomised Clinical Global Impression-Improvement scale (CGI-I) (improvement vs no change or worsening) at 4 months, assessed by investigators blinded to the allocated treatment was the primary outcome. Subsequently all patients were treated with BoNT in a ten month open-label phase.ResultsBetween January 2011 and February 2015 a total of 239 patients were screened for eligibility of whom 48 patients were included. No difference was found on the primary outcome (BoNT 16 of 25 (64.0%) vs Placebo 13 of 23 patients (56.5%); proportional difference 0.075 (95% CI -0.189 to 0.327; p=0.77). Secondary outcomes (symptom severity, disease burden, disability, quality of life and psychiatric symptoms) showed no between-group differences. The open-label phase showed improvement on the CGI-I in 19/43 (44.2%) of remaining patients, with a total of 35/43 (81.4%) improvement compared with baseline.ConclusionsIn this double-blind randomised controlled trial of BoNT for chronic jerky and tremulous FMD, we found no evidence of improved outcomes compared with placebo. Motor symptoms improved in a large proportion in both groups which was sustained in the open-label phase. This study underlines the substantial potential of chronic jerky and tremulous FMD patients to recover and may stimulate further exploration of placebo-therapies in these patients.Trial Registration NumberNTR2478.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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