Usability, safety and tolerability of CUE1 vibrotactile device as promising therapeutic approach in orthostatic tremor
Introduction: Primary Orthostatic Tremor (POT) is a rare hyperkinetic movement disorder characterized by unsteadiness while standing, often exacerbated by anxiety and fatigue. It significantly impairs quality of life, and current treatment options are limited, with invasive procedures carrying notab...
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Elsevier
2025-01-01
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| Series: | Clinical Parkinsonism & Related Disorders |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2590112525000830 |
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| author | Viktoria Azoidou Alexandra Zirra Thomas Boyle David Gallagher Alastair John Noyce Cristina Simonet |
| author_facet | Viktoria Azoidou Alexandra Zirra Thomas Boyle David Gallagher Alastair John Noyce Cristina Simonet |
| author_sort | Viktoria Azoidou |
| collection | DOAJ |
| description | Introduction: Primary Orthostatic Tremor (POT) is a rare hyperkinetic movement disorder characterized by unsteadiness while standing, often exacerbated by anxiety and fatigue. It significantly impairs quality of life, and current treatment options are limited, with invasive procedures carrying notable risks. Methods: This unblinded interventional study assessed the usability, safety, and tolerability of the CUE1, a non-invasive vibrotactile stimulation device worn on the sternum. Secondary exploratory outcomes included objective measures of balance and mobility: maximal stance time, tandem walk, heel raise hold, tandem stance, and Timed Up and Go (TUG) with and without dual tasking (DT). Assessments were performed at baseline, immediately after a 20-minute acclimatization session, and after 9 weeks of daily use (8 h/day). Patient-reported outcomes on fatigue, anxiety, and perceived change were also collected. Results: Ten participants with POT (70 % female, aged 58–88 years) completed the study. Compliance and tolerability were excellent (100 %), with only mild, transient skin irritation reported in two cases. Immediate post-intervention improvements were observed in TUG [-1.22 s (95 % CI: −2.03, −0.26), p = 0.020], tandem stance [+1.41 s (0.00, 6.13), p = 0.025], tandem walk [+0.50 steps (0.00, 2.50), p = 0.042], and heel raise hold [+1.62 s (1.00, 3.32), p = 0.020]. After 9 weeks, improvements were observed in TUG [-2.13 s (−4.00, −0.26), p = 0.028], TUG-DT [-7.51 s (−14.88, −0.14), p = 0.047], tandem stance [+9.06 s (1.04, 17.08), p = 0.028], fatigue [-7.00 (−13.63, −0.37), p = 0.035], and patient-reported impression of change [+1.10 (0.14, 2.06), p = 0.027]. Conclusion: CUE1 vibrotactile stimulation is safe, well-tolerated, and shows promise in improving balance, mobility, and fatigue in POT. Larger, controlled trials are warranted. |
| format | Article |
| id | doaj-art-a5c078ba4c58437e9ea0b2fe59332002 |
| institution | Kabale University |
| issn | 2590-1125 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Elsevier |
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| series | Clinical Parkinsonism & Related Disorders |
| spelling | doaj-art-a5c078ba4c58437e9ea0b2fe593320022025-08-20T03:44:27ZengElsevierClinical Parkinsonism & Related Disorders2590-11252025-01-011310037910.1016/j.prdoa.2025.100379Usability, safety and tolerability of CUE1 vibrotactile device as promising therapeutic approach in orthostatic tremorViktoria Azoidou0Alexandra Zirra1Thomas Boyle2David Gallagher3Alastair John Noyce4Cristina Simonet5Centre for Preventive Neurology, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom; Corresponding authors at: Centre for Preventive Neurology, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.Centre for Preventive Neurology, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United KingdomOlder Person’s Services & GIM Special Interest in Parkinson’s Disease, Royal London Hospital, United KingdomDepartment of Neurology, Royal London Hospital, Barts Health, London, United KingdomCentre for Preventive Neurology, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom; Department of Neurology, Royal London Hospital, Barts Health, London, United KingdomCentre for Preventive Neurology, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom; Neurology Department, Homerton Healthcare NHS Foundation Trust, United Kingdom; Corresponding authors at: Centre for Preventive Neurology, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.Introduction: Primary Orthostatic Tremor (POT) is a rare hyperkinetic movement disorder characterized by unsteadiness while standing, often exacerbated by anxiety and fatigue. It significantly impairs quality of life, and current treatment options are limited, with invasive procedures carrying notable risks. Methods: This unblinded interventional study assessed the usability, safety, and tolerability of the CUE1, a non-invasive vibrotactile stimulation device worn on the sternum. Secondary exploratory outcomes included objective measures of balance and mobility: maximal stance time, tandem walk, heel raise hold, tandem stance, and Timed Up and Go (TUG) with and without dual tasking (DT). Assessments were performed at baseline, immediately after a 20-minute acclimatization session, and after 9 weeks of daily use (8 h/day). Patient-reported outcomes on fatigue, anxiety, and perceived change were also collected. Results: Ten participants with POT (70 % female, aged 58–88 years) completed the study. Compliance and tolerability were excellent (100 %), with only mild, transient skin irritation reported in two cases. Immediate post-intervention improvements were observed in TUG [-1.22 s (95 % CI: −2.03, −0.26), p = 0.020], tandem stance [+1.41 s (0.00, 6.13), p = 0.025], tandem walk [+0.50 steps (0.00, 2.50), p = 0.042], and heel raise hold [+1.62 s (1.00, 3.32), p = 0.020]. After 9 weeks, improvements were observed in TUG [-2.13 s (−4.00, −0.26), p = 0.028], TUG-DT [-7.51 s (−14.88, −0.14), p = 0.047], tandem stance [+9.06 s (1.04, 17.08), p = 0.028], fatigue [-7.00 (−13.63, −0.37), p = 0.035], and patient-reported impression of change [+1.10 (0.14, 2.06), p = 0.027]. Conclusion: CUE1 vibrotactile stimulation is safe, well-tolerated, and shows promise in improving balance, mobility, and fatigue in POT. Larger, controlled trials are warranted.http://www.sciencedirect.com/science/article/pii/S2590112525000830Vibrotactile stimulationOrthostatic tremorAnxiety, fatigueBalance control |
| spellingShingle | Viktoria Azoidou Alexandra Zirra Thomas Boyle David Gallagher Alastair John Noyce Cristina Simonet Usability, safety and tolerability of CUE1 vibrotactile device as promising therapeutic approach in orthostatic tremor Clinical Parkinsonism & Related Disorders Vibrotactile stimulation Orthostatic tremor Anxiety, fatigue Balance control |
| title | Usability, safety and tolerability of CUE1 vibrotactile device as promising therapeutic approach in orthostatic tremor |
| title_full | Usability, safety and tolerability of CUE1 vibrotactile device as promising therapeutic approach in orthostatic tremor |
| title_fullStr | Usability, safety and tolerability of CUE1 vibrotactile device as promising therapeutic approach in orthostatic tremor |
| title_full_unstemmed | Usability, safety and tolerability of CUE1 vibrotactile device as promising therapeutic approach in orthostatic tremor |
| title_short | Usability, safety and tolerability of CUE1 vibrotactile device as promising therapeutic approach in orthostatic tremor |
| title_sort | usability safety and tolerability of cue1 vibrotactile device as promising therapeutic approach in orthostatic tremor |
| topic | Vibrotactile stimulation Orthostatic tremor Anxiety, fatigue Balance control |
| url | http://www.sciencedirect.com/science/article/pii/S2590112525000830 |
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