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The Validation of Tremor-Cancelling Technologies Needs a Multidisciplinary Consensus Statement

Authors:

Roberto López-Blanco ,

Integrated Neurology Department, Hospital Universitario Rey Juan Carlos (Móstoles), Hospital General de Villalba and Hospital Universitario Infanta Elena (Valdemoro), Madrid; Medicine Department, Faculty of Medicine, Universidad Complutense Madrid, ES
About Roberto

robretolb@gmail.com

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Julián Benito-León,

Medicine Department, Faculty of Medicine, Universidad Complutense Madrid; Neurology Department, University Hospital “12 de Octubre,” Madrid; Healthcare Research Institute Hospital 12 de Octubre (i+12), Madrid; Center of Biomedical Network Research on Neurodegenerative Diseases (CIBERNED), Madrid, ES
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Jesús Hernández-Gallego,

Medicine Department, Faculty of Medicine, Universidad Complutense Madrid; Neurology Department, University Hospital “12 de Octubre,” Madrid, ES
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Álvaro Sánchez-Ferro

Neurosciences Research Center (HM-CINAC) and Neurology Department, Hospital HM Puerta del Sur, Móstoles, Madrid, ES
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Abstract

How to Cite: López-Blanco R, Benito-León J, Hernández-Gallego J, Sánchez-Ferro Á. The Validation of Tremor-Cancelling Technologies Needs a Multidisciplinary Consensus Statement. Tremor and Other Hyperkinetic Movements. 2020;10. DOI: http://doi.org/10.5334/tohm.530
1
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  Published on 26 Feb 2020
 Accepted on 31 Jan 2020            Submitted on 13 Jan 2020

Dear Editor

We read with interest the review by Castrillo-Fraile et al.1 on tremor-control devices for essential tremor (ET). This is the first clinical review in which these systems have been analyzed thoroughly and helps to fill in the knowledge gap regarding the role of these technologies in assisting ET patients. However, there are three aspects that need further development.

First, tremor-cancelling devices are based on different approaches: wearable exoskeletons, orthoses, and handheld external devices, such as spoons. Nevertheless, computer softwares or hardwares to control kinetic tremor caused due to the mouse of a PC in ET patients were not included in this review.2,3 It would be interesting to consider them in upcoming studies due to their potential applications in daily-life and industries.

Second, as the authors emphasize in their systematic review, the evidence documented so far is scant, partly due to the different methodologies and the scarce number of subjects included in these studies. We would also like to underline the lack of independent testing outside the initial ones and also the scant publications of negative studies, which are crucial to understand important methodological and technological issues that could surely result in the improved development of otherwise encouraging solutions.4,5

Finally, in this review, some methodological aspects are discussed, such as the body location, the clinical outcomes used and some technological features of certain tremor-cancelation prototypes. However, in our opinion, the authors missed a key methodological issue, which is the inherent variability of tremor intensity during testing.6 This is something that we have consistently observed in various research studies related to tremor-cancelling systems even after modifying the test length and the temporal windows used in the analyses.711 Importantly, nonstimulation periods may even show greater tremor-intensity fluctuations when testing a novel device4 as compared to those used for stimulation. This issue can confound the interpretation of testing protocols that do not include long enough nonstimulation periods, although their ideal duration also remains to be defined.

Besides, considering these issues in future studies, a more permanent solution might include the creation of a multidisciplinary group that establishes consensus statements on recommendable methodologies for validating tremor-cancelling technologies, similarly to what is happening in other movement disorders.1214

Notes

1 In Response To: 

Castrillo-Fraile V, Peña EC, Gabriel Y, Galán JMT, Delgado-López PD, Collazo C, Cubo E. Tremor control devices for essential tremor: a systematic literature review. Tremor Other Hyperkinet Mov. 2019;9. doi: 10.7916/tohm.v0.688

2 Citation: López-Blanco R, Benito-León J, Hernández-Gallego J, Sánchez-Ferro Á. The Validation of Tremor-Cancelling Technologies Needs a Multidisciplinary Consensus Statement. Tremor Other Hyperkinet Mov. 2020: 10. doi: 10.7916/tohm.v0.765 

3 Editor: Elan D. Louis, Yale University, USA 

4 Funding: None. 

5 Financial Disclosures: None. 

6 Conflict of Interest: The authors report no conflict of interest. 

7 Ethics Statement: Not applicable for this category of article. 

References

  1. Castrillo-Fraile, V , Peña, EC , Gabriel, Y , Galán, JMT , Delgado-López, PD , Collazo, C , et al. Tremor control devices for essential tremor: a systematic literature review. Tremor Other Hyperkinet Mov 2019;9:1–6. 

  2. SteadyMouse, LLC The Steady Mouse Project. 2019 Available from: https://www.steadymouse.com/ [cited 28 Dec 2019]. 

  3. Rocon, E, , Miranda, JA , Pons, JL, TechFilter: filtering undesired tremorous movements from PC mouse cursor. Technol Disabil 2006;18(1):3–8. doi: https://doi.org/10.3233/TAD-2006-18101 

  4. Lora-Millán, JS, , López-Blanco, R, , Gallego, JÁ and , Méndez-Guerrero, A, , González de la Aleja, J, , Rocon, E, Mechanical vibration does not systematically reduce the tremor in essential tremor patients. Sci Rep 2019;9(1):16476. doi: https://doi.org/10.1038/s41598-019-52988-831712728 

  5. Petty, S and , Gross, RA, Neurology® null hypothesis: a special supplement for negative, inconclusive, or confirmatory studies. Neurology 2018;91(1):12–13. doi: https://doi.org/10.1212/WNL.000000000000580329884738 

  6. Cleeves, L and , Findley, LJ, Variability in amplitude of untreated essential tremor. J Neurol Neurosurg Psychiatry 1987;50(6):704–708. doi: https://doi.org/10.1136/jnnp.50.6.7043612150 

  7. Heo, JH , Kim, JW , Kwon, Y , Lee, SK , Eom, GM , Kwon, DY , et al. Sensory electrical stimulation for suppression of postural tremor in patients with essential tremor. Biomed Mater Eng 2015;26:S803–S809. doi: https://doi.org/10.3233/BME-15137226406077 

  8. Dosen, S , Muceli, S , Dideriksen, JL , Romero, JP , Rocon, E , Pons, J , et al. Online tremor suppression using electromyography and low-level electrical stimulation. IEEE Trans Neural Syst Rehabil Eng 2015;23(3):385–395. doi: https://doi.org/10.3233/BME-15137225051555 

  9. Dideriksen, JL , Laine, CM , Dosen, S , Muceli, S , Rocon, E , Pons, JL , et al. Electrical stimulation of afferent pathways for the suppression of pathological tremor. Front Neurosci 2017;11:178. doi: https://doi.org/10.3389/fnins.2017.0017828420958 

  10. Gallego, JÁ, , Rocon, E and , Belda-Lois, JM, , Pons, JL, A neuroprosthesis for tremor management through the control of muscle co-contraction. J Neuroeng Rehabil 2013;10(36):1–13. doi: https://doi.org/10.1186/1743-0003-10-3623336711 

  11. Rocon, E, , Belda-Lois, JM, , Ruiz, AF and , Manto, M, , Moreno, JC, , Pons, JL, Design and validation of a rehabilitation robotic exoskeleton for tremor assessment and suppression. IEEE Trans Neural Syst Rehabil Eng 2007;15(1):367–378. doi: https://doi.org/10.1109/TNSRE.2007.90391717894269 

  12. Espay, AJ , Hausdorff, JM , Sanchez-Ferro, A , Klucken, J , Merola, A , Bonato, P , et al. A roadmap for implementation of patient-centered digital outcome measures in Parkinson’s disease obtained using mobile health technologies. Mov Disord 2019;34(5):657–663. doi: https://doi.org/10.1002/mds.2767130901495 

  13. Artusi, CA , Mishra, M , Latimer, P , Vizcarra, JA , Lopiano, L , Maetzler, W , et al. Integration of technology-based outcome measures in clinical trials of Parkinson and other neurodegenerative diseases. Parkinsonism Relat Disord 2018;46 Suppl 1:S53–S56. doi: https://doi.org/10.1016/j.parkreldis.2017.07.02228760593 

  14. Maetzler, W, , Klucken, J , Horne, M, A clinical view on the development of technology-based tools in managing Parkinson’s disease. Mov Disord 2016;31(9):1263–1271. doi: https://doi.org/10.1002/mds.2667327273651 

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