UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034216