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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029958
Receipt No. 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 2017/11/20

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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
Middle name
Last name Takao Nozaki
Organization Hamamatsu University School of Medicine
Division name Department of Neurosurgery
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatus, Japan
TEL 053-435-2283
Email tnozaki@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Nozaki
Organization Hamamatsu University School of Medicine
Division name Department of Neurosurgery
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatus, Japan
TEL 053-435-2283
Homepage URL
Email tnozaki@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Anticipated trial start date
2018 Year 01 Month 09 Day
Last follow-up date
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
2017 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034216

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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