UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029958 |
|---|---|
| Receipt number | R000034216 |
| Scientific Title | Effect of subthalamic nucleus deep brain stimulation on gait and psychic function focusing on serotonergic nerve. |
| Date of disclosure of the study information | 2017/11/20 |
| Last modified on | 2022/05/18 15:23:42 |
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Basic information
Public title
Effect of subthalamic nucleus deep brain
stimulation on gait and psychic function
focusing on serotonergic nerve.
Acronym
Effect of STN-DBS on gait and psychic function focusing on serotonin.
Scientific Title
Effect of subthalamic nucleus deep brain
stimulation on gait and psychic function
focusing on serotonergic nerve.
Scientific Title:Acronym
Effect of STN-DBS on gait and psychic function focusing on serotonin.
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to evaluate
serotonergic systems in patients with
Parkinson's disease after subhtalamic nucleus
deep brain stimulation using Positron Emission Tomography (PET), and to assess the
relationship between improvement of gait,
psychiatric function and serotonergic systems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Binding potentials of [11C]N,N dimethyl 2
(2 amino 4 cyanophenylthio)benzylamine
([11C]DASB) PET.
Comparison between preoperative bindings and those of six months after surgery.
Binding potentials of patients who had operated five to eight years before are also evaluated.
Key secondary outcomes
[11C] 2 carbomethoxy 3b (4 fluorophenyl) tropane ( [11C] CFT) PET is also performed for the same patient, and the binding potential is evaluated in the same way.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
[11C]DASB-PET
Interventions/Control_2
[11C]DASB-PET
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who agree to discontinue of oral administration of antiparkinson drugs just before examination.
2. Patients who agree to PET examination.
3. Patients with 40 to 75 years of age when obtaining consent.
4. Patients who were obtained consent for this research for himself or herself.
Key exclusion criteria
1. Female patients who are pregnant or planning to become pregnant.
2. Patients with cognitive impairment, aphasia, psychiatric disorders, higher brain dysfunction, suicidal desires, antidepressant drugs. Patients who are taking antidepressant or antipsychotic medications.
3. Patients who are judged by researchers as inappropriate to participate in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Nozaki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Neurosurgery
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatus, Japan
TEL
053-435-2283
tnozaki@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Nozaki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Neurosurgery
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatus, Japan
TEL
053-435-2283
Homepage URL
tnozaki@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hamamatsu Photonics KK
Hamamatus Medical Photonics Foundation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reserch Promotion section, Reserch Support Division, Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatus, Japan
Tel
053-435-2680
rinri@hama-med.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
| 2017 | Year | 11 | Month | 20 | 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
| 2017 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 13 | Day |
Last modified on
| 2022 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034216
