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May. 09, 2022 |
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July. 31, 2024 |
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jRCTs062220013 |
Investigation of the swallowing function using interferential current sensor |
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Swallowing function with current sensory stimulation for Parkinson's disea |
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June. 30, 2023 |
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25 |
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We evaluated the 25 patients with Hoehn Yahr stage 2 to 4 Parkinson's disease. The average age was 72.0 years, with 9 female participants. The median duration of illness was 6 years, and the median Hoehn and Yahr stage was 3. The median UPDRS score (total) was 37, and the median UPDRS score (part 3) was 23. |
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Initially, 27 participants were registered, but due to personal reasons, two individuals withdrew their participation in the study within four weeks. As a result, interventions and evaluations were conducted without deviation for the remaining 25 participants. |
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Adverse events related to the intervention, such as worsened cervical skin or neurological symptoms due to stimulation, did not occur. |
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In the primary endpoint, the percentage of participants with a normal cough reflex, the 1% citric acid test, significantly increased at the end of the intervention. In the secondary endpoints, the proportion of patients with a normal cough reflex in the 1% citric acid cough test improved 8 weeks after the intervention, and the percentage of participants with a normal cough reflex in the simplified 1% citric acid cough test improved at both the end of the intervention and 8 weeks after. The proportion of participants with a normal swallowing status (EAT-10) also improved at the end of the intervention and 8 weeks after. No significant decrease in aspiration and laryngeal penetration rates during swallowing, as analyzed by videofluoroscopic swallowing study, was observed at the end of the intervention and 8 weeks after. There were no cases of pneumonia during the entire 16-week observation period. |
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The 8-week intervention trial of cervical sensory nerve electrical stimulation in patients with Parkinson's disease revealed improvements in cough tests and swallowing function. There were no occurrences of pneumonia during the course of the study. |
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July. 31, 2024 |
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Oct. 10, 2023 |
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https://www.sciencedirect.com/science/article/pii/S0022510X23002927?via%3Dihub |
No |
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There are no plans for sharing. |
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https://jrct.mhlw.go.jp/latest-detail/jRCTs062220013 |
Maruyama Hirofumi |
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Hiroshima University Hospital |
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1-2-3, Kasumi, Minami-ku, Hiroshima |
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+81-82-257-5201 |
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hmaru@hiroshima-u.ac.jp |
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Nakamori Masahiro |
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Hiroshima University Hospital |
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1-2-3, Kasumi, Minami-ku, Hiroshima |
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+81-82-257-5201 |
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mnakamori1@gmail.com |
Complete |
May. 09, 2022 |
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| June. 01, 2022 | ||
| 27 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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Diagnosed as Parkinson's disease |
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Using pacemaker or implantable cardioverter defi |
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| 20age old over | ||
| 85age old under | ||
Both |
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Parkinson's Disease |
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Using low-frequency stimulation device |
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Parkinson's disease, neurodegenerative disease |
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interferential current sensory stimulation, Parkinson's disease |
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20052621 (ICD10) |
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Percentage of patients with normal coughing reflection by coughing test at the end of intervention |
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Percentage of patients with normal coughing reflection by coughing test after 8 weeks from the end of intervention. |
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| Grant-in-aid for scientific research | |
| Not applicable |
| Hiroshima University Certified Review Board | |
| 1-2-3 Kasumi, Minami-ku, Hiroshima, Japan, Hiroshima | |
+81-82-257-1551 |
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| iryo-seisaku@office.hiroshima-u.ac.jp | |
| Approval | |
April. 25, 2022 |
none |