UMIN-CTR Clinical Trial

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

Parkinson's disease

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Factorial

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Hamamatsu Photonics KK
Hamamatus Medical Photonics Foundation

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

11

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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