A word of hope for ataxia trials in COVID-19 time and beyond
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SHORT COMMENTARY
A word of hope for ataxia trials in COVID‑19 time and beyond Roderick P. P. W. M. Maas1 · Jordache Ramjith2 · Thomas Klockgether3,4 · Kit C. B. Roes2 · Bart P. C. van de Warrenburg1 Received: 24 June 2020 / Accepted: 15 September 2020 © The Author(s) 2020
Abstract The coronavirus disease 2019 (COVID-19) crisis confronted us, like many researchers worldwide, with an unforeseen challenge during the final stages of a randomized controlled trial involving ataxia patients. Institutional guidelines suddenly no longer allowed regular follow-up visits to take place, impeding the clinical evaluation of long-term outcomes. Here, we discuss the various scenarios that we considered in response to these imposed restrictions and share our experience of home video recording by dedicated, extensively instructed family members. Albeit somewhat unconventional at first glance, this last resort strategy enabled us to reliably assess the study’s primary endpoint at the predefined point in time and hopefully encourages researchers in other ongoing ataxia trials to continue their activities. Remote assessments of ataxia severity may serve as a reasonable substitute in interventional trials beyond the current exceptional situation generated by the COVID-19 pandemic, but will require further investigation. Keywords Cerebellar ataxia · Randomized controlled trial · COVID-19 · Scale for the assessment and rating of ataxia
The current coronavirus pandemic profoundly impacts patient care, medical education, and scientific research activities. Adaptation, flexibility, creativity, and problemsolving skills are highly required and more necessary than ever before. At the same time, institutional, national, and international guidelines must be followed accurately in order to prevent further transmission of the virus. Like many ongoing studies, our randomized, double-blind, shamcontrolled SCA3-tDCS trial—in which we examine the effects of cerebellar transcranial direct current stimulation (tDCS) in twenty patients with spinocerebellar ataxia type * Roderick P. P. W. M. Maas [email protected] 1
Department of Neurology, Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Center, Reinier Postlaan 4, 6525 GC Nijmegen, The Netherlands
2
Department of Health Evidence, Section Biostatistics, Radboud University Medical Center, Nijmegen, The Netherlands
3
Department of Neurology, University of Bonn, Bonn, Germany
4
German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany
3 (SCA3)—is affected by the health security measures dictated by the authorities and hospital board [1]. We here aim to share our experience by sketching the different scenarios that we considered for our study and end with a possible solution that may inspire investigators in ongoing ataxia trials to continue their research activities. When the COVID-19 crisis struck the Netherlands, our study had fortunately reached its final stage. All participants had completed the 10-day regimen of daily tDCS session
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