Unique ID issued by UMIN | UMIN000044246 |
---|---|
Receipt number | R000050531 |
Scientific Title | An open-label, unblinded, exploratory study to evaluate the eye movement in Parkinson disease patients |
Date of disclosure of the study information | 2021/05/18 |
Last modified on | 2023/07/05 17:05:12 |
An exploratory study to evaluate the eye movement in Parkinson disease
ExSEM-PD
An open-label, unblinded, exploratory study to evaluate the eye movement in Parkinson disease patients
ExSEM-PD
Japan |
Parkinson disease
Neurology |
Others
NO
The aim of the study is to investigate the correlation between eye movement, clinical evaluation scales and plasma levodopa concentration during administration of levodopa in Parkinson's disease patients.
Others
Pathophysiology
Exploratory
Not applicable
1. Clinical evaluation scales for Parkinson disease (Hoehn-Yahr, MDS-UPDRS, UDysRS, patient diary, PDQ-39, and EQ-5D-5L)
2. Eye movement (saccadic movement, eye blinks, eye blink speed, etc.)
3. Plasma levodopa concentration
Observational
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1. Clinically established or probable Parkinson disease meeting the MDS clinical diagnosis criteria for Parkinson disease (2015)
2. Stage <= III on the Hoehn and Yahr scale in the ON state
3. Receiving treatment with L-DOPA for >= 6 months (26 weeks) and have been shown to be effective at the beginning of the administration
4. Advanced PD who will be hospitalized for medical evaluation, drug adjustment, and rehabilitation
5. Either hospitalized patient or outpatient
6. capable of giving a voluntary written informed consent after sufficient understanding of the research
7. Among those who use eyeglasses, those who can spend 6 hours corresponding to the evaluation time without using their own eyeglasses
1. Atypical Parkinsonism syndromes
2. Dementia or at high risk of it (Mini Mental State Examination (MMSE) score < = 20)
3. Contraindicated for concomitant medications (L-DOPA / carbidopa)
4. Hypersensitivity to concomitant medications (L-DOPA / carbidopa) and/or their ingredients
5. Co-existing psychiatric disease (e.g., depression, bipolar disorder or schizophrenia) and/or clinically significant complications (e.g., cerebrovascular accident, heart disease, chronic respiratory disease, uncontrolled hypertension and diabetes)
6. History of psychiatric disease (e.g., depression, bipolar disorder or schizophrenia) and/or device-aided therapies (i.e., GPi pallidotomy, thalamotomy, and deep brain stimulation)
7. Those who are judged by the principal investigator to be inappropriate as research subjects
20
1st name | Noriko |
Middle name | |
Last name | Nishikawa |
Juntendo University School of Medicine
Department of Neurology
113-8431
3-1-3, Hongou, Bunkyo-ku, Tokyo 113-8431 Japan
03-3813-3111
n.nishikawa.ts@juntendo.ac.jp
1st name | Noriko |
Middle name | |
Last name | Nishikawa |
Juntendo University School of Medicine
Department of Neurology
113-8431
3-1-3, Hongou, Bunkyo-ku, Tokyo 113-8431 Japan
03-3813-3111
n.nishikawa.ts@juntendo.ac.jp
Department of Neurology
Juntendo University School of Medicine
Sumitomo Dainippon Pharma Co., Ltd.
Profit organization
Sumitomo Dainippon Pharma Co., Ltd.
the Ethical Review Committee of Juntendo University Faculty of Medicine
3-1-3, Hongou, Bunkyo-ku, Tokyo 113-8431 Japan
03-3813-3111
kenkyu5858@juntendo.ac.jp
NO
順天堂大学医学部附属順天堂医院 (東京都)
Juntendo University Hospital (Tokyo, Japan)
大日本住友製薬株式会社 大阪研究所 (大阪府)
Sumitomo Dainippon Pharma, Osaka Research Center (Osaka, Japan)
2021 | Year | 05 | Month | 18 | Day |
https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=web&cd=&ved=0CAIQw7AJahcKEwigofnAjff_AhUAAAAA
Unpublished
https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=web&cd=&ved=0CAIQw7AJahcKEwigofnAjff_AhUAAAAA
20
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.
2023 | Year | 07 | Month | 05 | Day |
Parkinson's disease patient with wearing-off phenomenon
Twenty cases were recruited, all of whom carried out the study.
none
MDS-UPDRS part 3
Blink imformation
No longer recruiting
2021 | Year | 02 | Month | 12 | Day |
2021 | Year | 03 | Month | 18 | Day |
2021 | Year | 05 | Month | 17 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
The aim of present study is to investigate the correlation between eye movement, clinical evaluation scale and plasma levodopa concentration during administration of levodopa in Parkinson's disease patients.
2021 | Year | 05 | Month | 18 | Day |
2023 | Year | 07 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050531