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Japanese

May. 09, 2022

July. 31, 2024

jRCTs062220013

Investigation of the swallowing function using interferential current sensor
y stimulation for Parkinson's disease patients: a single arm intervention stu
dy

Swallowing function with current sensory stimulation for Parkinson's disea
se

June. 30, 2023

25

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.

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.

Adverse events related to the intervention, such as worsened cervical skin or neurological symptoms due to stimulation, did not occur.

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.

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.

July. 31, 2024

Oct. 10, 2023

https://www.sciencedirect.com/science/article/pii/S0022510X23002927?via%3Dihub

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There are no plans for sharing.

https://jrct.mhlw.go.jp/latest-detail/jRCTs062220013

Maruyama Hirofumi

Hiroshima University Hospital

1-2-3, Kasumi, Minami-ku, Hiroshima

+81-82-257-5201

hmaru@hiroshima-u.ac.jp

Nakamori Masahiro

Hiroshima University Hospital

1-2-3, Kasumi, Minami-ku, Hiroshima

+81-82-257-5201

mnakamori1@gmail.com

Complete

May. 09, 2022

June. 01, 2022
27

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Diagnosed as Parkinson's disease
Hoehn Yahr stage is from 2 to 4
No change of levodopa during 1 month before the
inclusion.
Capable of visiting hospital twice a week

Using pacemaker or implantable cardioverter defi
brillator
Patients who is pregnant or will be pregnant
Past history of head and neck cancer or surgery
Active pneumonia
Receiving rehabilitation of swallowing

20age old over
85age old under

Both

Parkinson's Disease

Using low-frequency stimulation device

Parkinson's disease, neurodegenerative disease

interferential current sensory stimulation, Parkinson's disease

20052621 (ICD10)

Percentage of patients with normal coughing reflection by coughing test at the end of intervention

Percentage of patients with normal coughing reflection by coughing test after 8 weeks from the end of intervention.
Increment of provocative rate during 30 seconds after starting the coughing test at the end of intervention and after 8 weeks from the end of intervention.
Percentage of patients with normal swallowing function at the end of intervention and after 8 weeks from the end of intervention.
Reduction of aspiration or laryngeal penetration analyzed by swallowing videofluorography at the end of intervention and after 8 weeks from the end of intervention.
Presence of pneumonia during the whole period.

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

iryo-seisaku@office.hiroshima-u.ac.jp
Approval

April. 25, 2022

none

History of Changes

No Publication date
4 July. 31, 2024 (this page) Changes
3 Mar. 15, 2023 Detail Changes
2 Dec. 05, 2022 Detail Changes
1 May. 09, 2022 Detail