UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051871 |
|---|---|
| Receipt number | R000058789 |
| Scientific Title | A multicenter validation study to create a model to predict Parkinson's disease motor symptom scores from blink information in patients with Parkinson's disease. |
| Date of disclosure of the study information | 2023/08/09 |
| Last modified on | 2024/04/04 22:39:53 |
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Basic information
Public title
A multicenter validation study to create a model to predict Parkinson's disease motor symptom scores from blink information in patients with Parkinson's disease.
Acronym
Multicenter Blink study
Scientific Title
A multicenter validation study to create a model to predict Parkinson's disease motor symptom scores from blink information in patients with Parkinson's disease.
Scientific Title:Acronym
A multicenter validation study to create a model to predict Parkinson's disease motor symptom scores from blink information in patients with Parkinson's disease.
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have previously found that L-dopa medication increases blink frequency in patients with advanced PD using an ophthalmic device and that plasma L-dopa concentration correlates with blink frequency ("An uncontrolled, open-label, exploratory clinical study on the association analysis of ocular information using an ophthalmic device in patients with PD (UMIN:000044246)"). An uncontrolled, open-label, exploratory clinical study of the association analysis of ocular information using an ophthalmic device in patients with PD (UMIN:000044246)"). In this previous study, the MDS-UPDRS Part III score of PD motor symptoms, the ON/OFF score of the patient symptom diary, and the L-dopa blood concentration showed similar trends to the blink frequency. Furthermore, by extracting various parameters such as blink duration and confidence from the blink information and applying machine learning, we constructed a model to estimate clinical symptoms at the same point in time from 3 minutes of blink data. UPDRS Part III score in real time.
Based on these results, we believe that "blinking eyes" can be a simple, non-invasive biomarker that reflects PD symptoms in real time, and we decided to validate this model in a multicenter study with a larger number of patients.
Basic objectives2
Others
Basic objectives -Others
To create a model to infer motor symptoms of Parkinson's disease from blink information.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Concordance between motor symptom scores inferred from blink information and actual MDS-UPDRS Part 3 scores obtained by neurologists.
Key secondary outcomes
Percentage of concordance between dyskinesia estimated from blink information and actual dyskinesia.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Age between 20 and 90 years old at the time of obtaining consent.
2) Patients who have been diagnosed with Parkinson's disease (clinically confirmed or almost clinically certain) according to the "Clinical Diagnostic Criteria for MDS Parkinson's Disease (PD) (2015)".
(3) Patients who have received a thorough explanation of their participation in this study, and who have given their free and voluntary written consent based on a thorough understanding of the study.
Key exclusion criteria
(1) Patients with Parkinson's syndrome other than Parkinson's disease
(2) Patients under treatment for dry eye
(iii) Patients with cognitive impairment that makes it difficult to conduct the study
(4) Patients with any of the following complications
Psychiatric disorders (depression, bipolar disorder, schizophrenia, etc.)
Other serious complications (cerebrovascular disease, cardiac disease, chronic respiratory disease, uncontrolled hypertension, diabetes mellitus, etc.)
(5) Other patients who are deemed inappropriate as research subjects by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Nishikawa |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
03-3813-3111
n.nishikawa.ts@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Nishikawa |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
03-3813-3111
Homepage URL
n.nishikawa.ts@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Noriko Nishikawa
Funding Source
Organization
Sumitomo Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo, Tokyo
Tel
03-3814-5672
hongo-rinri@juntendo.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
順天堂大学医学部附属順天堂医院（東京都）、順天堂大学医学部附属練馬病院（東京都）、東京慈恵医科大学附属第三病院（東京都）、東京医科大学附属病院（東京都）、
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
During an outpatient visit or while hospitalized, the patient will record spontaneous blinks while wearing an eyeglass-type device and watching a video for 15 minutes while taking his/her usual therapeutic medications. Clinical symptoms of Parkinson's disease and other symptoms will be evaluated before and after wearing that eyeglass device. We examine whether the blink can be analyzed to predict Parkinson's disease motor symptom scores.
Management information
Registered date
| 2023 | Year | 08 | Month | 09 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058789
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