UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058937 |
|---|---|
| Receipt number | R000067403 |
| Scientific Title | Long-term Randomized Crossover Trial for Adaptive versus Conventional Deep Brain Stimulation in Parkinson's Disease |
| Date of disclosure of the study information | 2025/08/30 |
| Last modified on | 2025/08/30 11:26:19 |
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Basic information
Public title
Long-term Randomized Crossover Trial for Adaptive versus Conventional Deep Brain Stimulation in Parkinson's Disease
Acronym
Trial of a adaptive DBS Therapy for Parkinson's Disease
Scientific Title
Long-term Randomized Crossover Trial for Adaptive versus Conventional Deep Brain Stimulation in Parkinson's Disease
Scientific Title:Acronym
Trial of a adaptive DBS Therapy for Parkinson's Disease
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the long-term effects of adaptive deep brain stimulation (aDBS) compared with conventional DBS (cDBS) on daily functioning and motor symptoms in patients with Parkinson's disease, and to explore whether baseline clinical characteristics can predict differential treatment responses.
Basic objectives2
Others
Basic objectives -Others
This randomized, double-blind crossover trial aims to directly compare the clinical efficacy of aDBS and cDBS. The study also seeks to characterize inter-individual variability in treatment response and to explore whether baseline clinical features act as effect modifiers.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
- Daily ON time (hours per day, assessed by patient diaries; averaged over the final 7 days of each 1-month stimulation condition)
- Daily OFF time (hours per day, assessed by patient diaries; same evaluation period as above)
- Daily time with troublesome dyskinesia (hours per day, assessed by patient diaries; same evaluation period)
- Daily time with non-troublesome dyskinesia (hours per day, assessed by patient diaries; same evaluation period)
Key secondary outcomes
- UPDRS Part I score (ON state) (self-reported; assessed at the end of each 1-month stimulation condition)
- UPDRS Part II score (ON state) (self-reported; same evaluation period)
- UPDRS Part III score (ON state) (examiner-rated; same evaluation period)
- UPDRS Part IV score (ON state) (self-reported; same evaluation period)
- UPDRS total score (ON state) (sum of Parts I to IV; same evaluation period)
- Mini-Mental State Examination (MMSE) total score (examiner-administered cognitive test; same evaluation period)
- Schwab and England ADL scale (ON state) (examiner-rated; same evaluation period)
- Parkinson's Disease Questionnaire-39 (PDQ-39) summary index (self-administered; same evaluation period)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
adaptive deep brain stimulation (aDBS)
Interventions/Control_2
conventional deep brain stimulation (cDBS)
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Patients with a clinical diagnosis of Parkinson's disease presenting with motor complications (dyskinesia or motor fluctuations)
Key exclusion criteria
- Patients with cognitive impairment defined as Mini-Mental State Examination (MMSE) score < 24
- Patients with significant psychiatric disorders requiring treatment changes
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Hashimoto |
Organization
Aizawa Hospital
Division name
Department of Neurology
Zip code
390-0814
Address
2-5-1 Honjo, Matsumoto, Nagano 390-0814, Japan
TEL
+81-263-33-8600
halloevery1@live.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Hashimoto |
Organization
Aizawa Hospital
Division name
Department of Neurology
Zip code
390-0814
Address
2-5-1 Honjo, Matsumoto, Nagano 390-0814, Japan
TEL
+81-263-33-8600
Homepage URL
halloevery1@live.jp
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
Takao Hashimoto
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aizawa Hospital
Address
2-5-1 Honjo, Matsumoto, Nagano 390-0814, Japan
Tel
+81-263-33-8600
halloevery1@live.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
相澤病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 30 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067403
