UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053703 |
|---|---|
| Receipt number | R000061283 |
| Scientific Title | Circular skin needle for dysphagia in Parkinson's Disease. |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/02/25 22:05:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Circular skin needle for dysphagia in Parkinson's Disease.
Acronym
Effects of acupuncture treatment on dysphagia in patients with Parkinson's disease.
Scientific Title
Circular skin needle for dysphagia in Parkinson's Disease.
Scientific Title:Acronym
Circular skin needle for dysphagia in Parkinson's Disease.
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the effects of circular skin needle efficacy on Parkinson's Disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
RSST
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
circular skin needle
Interventions/Control_2
no treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Parkinson disease patients who are in stage 1 to 3 (HY) at the on period.
2)Not change taking medications within 3 months before starting this study.
3) Subjects who gave the written informed consent.
Key exclusion criteria
1)PD-related disorders and other neurodegenrative diseases.
2) The change of medications in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shimpei |
| Middle name | |
| Last name | Fukuda |
Organization
Niigata University of Health and Welfare
Division name
Department of Acupuncture and Moxibustion
Zip code
950-3198
Address
Shimami-cyo, Niigata-shi, Niigata, 950-3198, Japan
TEL
025-257-4455
shinpei-fukuda@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shimpei |
| Middle name | |
| Last name | Fukuda |
Organization
Niigata University of Health and Welfare
Division name
Department of Acupuncture and Moxibustion
Zip code
950-0823
Address
Shimami-cyo, Niigata-shi, Niigata, 950-3198, Japan
TEL
025-257-4455
Homepage URL
shinpei-fukuda@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
Shimami-cyo, Niigata-shi, Niigata, 950-3198, Japan
Tel
025-257-4455
shinpei-fukuda@nuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 25 | Day |
Last modified on
| 2024 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061283
