UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061054 |
|---|---|
| Receipt number | R000069821 |
| Scientific Title | A study on the effects of deep brain stimulation on blood pressure |
| Date of disclosure of the study information | 2026/03/26 |
| Last modified on | 2026/03/25 16:13:42 |
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Basic information
Public title
A study on the effects of deep brain stimulation on blood pressure
Acronym
Deep brain stimulation on blood pressure
Scientific Title
A study on the effects of deep brain stimulation on blood pressure
Scientific Title:Acronym
Deep brain stimulation on blood pressure
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Cardiology | Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of deep brain stimulation on blood pressure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Can the transfer function from deep brain stimulation to blood pressure be described and identified?
Key secondary outcomes
(1) Can a control center program be designed that allows the blood pressure servo system, which compensates for blood pressure drops, to operate most stably and rapidly?
(2) Can the degree of blood pressure drop upon standing be improved depending on the presence or absence of stimulation?
(3) Is there a correlation between the responsiveness of blood pressure to stimulation and the stimulation site identified by MRI?
(4) Is there a correlation with the degree of blood pressure drop while seated?
(5) Is blood pressure reactivity associated with the patient's clinical background?
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 with Parkinson disease undergoing deep brain stimulation who participated in the study between July 2012 and December 2020.
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Fumiyasu |
| Middle name | |
| Last name | Yamasaki |
Organization
Kochi Medical School Hospital
Division name
Clinical Laboratory
Zip code
783-8505
Address
185-1, Kohasu, Oko-cho, Nankoku, Kochi
TEL
088-866-5811
yamasaki-f@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumiyasu |
| Middle name | |
| Last name | Yamasaki |
Organization
Kochi Medical School Hospital
Division name
Clinical Laboratory
Zip code
783-8505
Address
185-1, Kohasu, Oko-cho, Nankoku, Kochi
TEL
088-866-5811
Homepage URL
yamasaki-f@kochi-u.ac.jp
Sponsor or person
Institute
Clinical Laboratory, Kochi Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Kochi Medical School Hospital
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
The Ethics Committee of Izumino Hospital
Address
2-10-53, Azono-Kitamachi, Kochi, Kochi
Tel
088-826-5511
masatos@izumino.or.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 | 03 | Month | 26 | 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
| 2012 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Parkinson disease, which most commonly affects middle-aged and older adults, is frequently associated with orthostatic hypotension. There is currently no treatment for drug-resistant orthostatic hypotension, and patients often become bedridden in the late stages of the disease.
Deep brain stimulation is effective against the primary motor symptoms of Parkinson disease, such as tremor, bradykinesia, and rigidity; however, its effects on blood pressure have not been fully elucidated. Therefore, we investigated the blood pressure response to deep brain stimulation.
We conducted these investigations and collected data from 2012 to 2020; we are now conducting an observational study to analyze this data and prepare a paper for publication.
If these results confirm the responsiveness of blood pressure to DBS, it will be possible to design and develop an artificial arterial pressure reflex device that incorporates DBS into its system, which could be applied to the treatment of Parkinson disease patients with severe orthostatic hypotension.
Methods:
We will conduct an observational study to analyze the following data collected between July 2012 and December 2020.
Analytical Methods:
(1) Description and identification of the transfer function from deep brain stimulation to blood pressure using random stimuli
(2) Design of a control center program that enables the blood pressure servo system, which compensates for blood pressure drops, to operate in the most stable and rapid manner
(3) Comparison and evaluation of the degree of blood pressure drop upon standing, with and without stimulation
(4) Comparison of the responsiveness of blood pressure to stimulation with the stimulation sites identified by MRI
(5) Examination of the degree of blood pressure drop in the seated position
(6) Comparison of blood pressure responsiveness with patients' clinical backgrounds
Management information
Registered date
| 2026 | Year | 03 | Month | 25 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069821
