UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062080 |
|---|---|
| Receipt number | R000071028 |
| Scientific Title | Study of Daily Life Activities and Psychological Status After Deep Brain Stimulation in Parkinson's Disease |
| Date of disclosure of the study information | 2026/06/27 |
| Last modified on | 2026/06/27 16:05:38 |
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Basic information
Public title
Study of Daily Life Activities and Psychological Status After Deep Brain Stimulation in Parkinson's Disease
Acronym
DBS-LifePsych Study
Scientific Title
Study of Daily Life Activities and Psychological Status After Deep Brain Stimulation in Parkinson's Disease
Scientific Title:Acronym
DBS-LifePsych Study
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the association of activities of daily living and physical activity with psychological factors after deep brain stimulation in patients with Parkinson's disease.
Basic objectives2
Others
Basic objectives -Others
Assessment of the association among activities of daily living, physical activity, and psychological factors after deep brain stimulation in patients with Parkinson's disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of Parkinson's disease: Unified Parkinson's Disease Rating Scale
Gait ability: Timed Up and Go test and 10-meter walk test
Cognitive function: Wechsler Adult Intelligence Scale, Fourth Edition; Japanese version of the Mini-Mental State Examination; Frontal Assessment Battery; and Trail Making Test
Psychological function: Hamilton Depression Rating Scale, Parkinson Anxiety Scale, Modified Falls Efficacy Scale, and Psychological Independence Scale
Activities of daily living: Functional Independence Measure
Quality of life: Parkinson's Disease Questionnaire-39
Physical activity: physical activity indices measured using an accelerometer
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with Parkinson's disease
Patients admitted to Kurashiki Heisei Hospital for the purpose of undergoing deep brain stimulation
Patients aged 65 years or older
Patients with a Mini-Mental State Examination score of 24 or higher, who are able to understand and respond to questionnaires and assessments
Patients who have received an explanation of the study and provided written informed consent
Key exclusion criteria
Patients with a Mini-Mental State Examination score of 23 or lower suggesting cognitive impairment, those with severe psychiatric disorders, those with severe physical comorbidities that make assessments difficult, and those judged by the principal investigator or co-investigators to be inappropriate for participation.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Hirata |
Organization
Kawasaki University of Medical Welfare
Division name
Faculty of Rehabilitation
Zip code
701-0193
Address
288 Matsushima, Kurashiki, Okayama
TEL
0864641109
kfmbs599@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Hirata |
Organization
Kawasaki University of Medical Welfare
Division name
Faculty of Rehabilitation
Zip code
701-0193
Address
288 Matsushima, Kurashiki, Okayama
TEL
0864641109
Homepage URL
kfmbs599@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
Kawasaki University of Medical Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki University of Medical Welfare
Address
288 Matsushima, Kurashiki, Okayama
Tel
0864621111
kfmbs599@mw.kawasaki-m.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
| 2026 | Year | 06 | Month | 27 | 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
| 2025 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-arm, prospective longitudinal observational study of patients with Parkinson's disease undergoing deep brain stimulation. Assessments will be conducted at three time points: before deep brain stimulation, 3 months after deep brain stimulation, and 1 year after deep brain stimulation. Disease severity, gait ability, cognitive function, psychological function, activities of daily living, quality of life, and physical activity will be evaluated. Physical activity will be measured using an accelerometer, and other outcomes will be assessed using clinical rating scales and questionnaires. This study will not intervene in the indication, implementation, or usual clinical care related to deep brain stimulation. The observational data will be used to examine the association of activities of daily living and physical activity with psychological factors after deep brain stimulation.
Management information
Registered date
| 2026 | Year | 06 | Month | 27 | Day |
Last modified on
| 2026 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071028
