UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052862 |
|---|---|
| Receipt number | R000060327 |
| Scientific Title | The effects of transcutaneous auricular vagus nerve stimulation on postural instability in patients with Parkinson's disease |
| Date of disclosure of the study information | 2023/11/22 |
| Last modified on | 2024/04/14 07:53:59 |
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Basic information
Public title
The effects of transcutaneous auricular vagus nerve stimulation on postural instability in patients with Parkinson's disease
Acronym
Transcutaneous auricular vagus nerve stimulation for postural instability in Parkinson's disease
Scientific Title
The effects of transcutaneous auricular vagus nerve stimulation on postural instability in patients with Parkinson's disease
Scientific Title:Acronym
Transcutaneous auricular vagus nerve stimulation for postural instability in Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the immediate effects of transcutaneous auricular vagus nerve stimulation on postural instability during standing and walking in Parkinson's disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcomes on postural instability during standing and walking
Key secondary outcomes
Motor symptoms, non-motor symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcutaneous auricular vagus nerve stimulation
Interventions/Control_2
Sham stimulation
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)Hoehn & Yahr stage 1-4
2)Individuals capable of standing and walking without physical or personal assistance
3)stable antiparkinsonian medication during at least three weeks
Key exclusion criteria
1)Coexistence of Neurological Disorders Other Than Parkinson's Disease
2)Deep Brain Stimulation Therapy
3)Metallic Substances in the Body
4)Decline in Cognitive Function
5)History of Cardiovascular Disease
6)Orthostatic Hypotension
7)Vagus Nerve Reflex
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Okada |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL
+81-745-54-1601
y.okada@kio.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Okada |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL
+81-745-54-1601
Homepage URL
y.okada@kio.ac.jp
Sponsor or person
Institute
Kio University
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
Ethics Review Committee of Kio University
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
Tel
+81-745-54-1601
y.okada@kio.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
| 2023 | Year | 11 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060327
