UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001185
Receipt number R000001442
Scientific Title Therapeutic application of the navigation-guided repetitive transcranial magnetic stimulation to mood disorder and vascular depression.
Date of disclosure of the study information 2008/06/12
Last modified on 2012/04/17 16:51:24

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Basic information

Public title

Therapeutic application of the navigation-guided repetitive transcranial magnetic stimulation to mood disorder and vascular depression.

Acronym

The navigation-guided repetitive transcranial magnetic stimulation.

Scientific Title

Therapeutic application of the navigation-guided repetitive transcranial magnetic stimulation to mood disorder and vascular depression.

Scientific Title:Acronym

The navigation-guided repetitive transcranial magnetic stimulation.

Region

Japan


Condition

Condition

Mood Disorder
Vascular Depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this clinical study is to evaluate clinical and biological effects of the navigation-guided rTMS applied to patients with mood disorder or vascular depression. Further, we are going to investigate any clinical or biological differences between responders and non-responders to rTMS.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

Before the first rTMS session, Hamilton Depression Rating Scale (Ham-D) and Beck Depression Inventory (BDI) are performed as clinical evaluation. Mini Mental State Examination and Wechsler Adult Intelligence Scale 3rd Edition (WAIS-III) are performed as cognitive evaluation, and also executive functions related to prefrontal region, such as Wisconsin Card Sorting Test (WCST), Trail Making Test (TMT), Color Stroop Test (CST), and Iowa Gambling Test (IGT), are evaluated as cognitive outcomes. 2 weeks after the initiation of rTMS sessions, clinical scales (Ham-D and BDI) are weekly evaluated until the end of rTMS sessions. After the final rTMS session, neuropsychological testings related to prefrontal executive functions are reevaulated.

Key secondary outcomes

To evaluate safety of rTMS sessions, we check any potential side effects at each rTMS session using side effects questionnaire, which was translated in Japanese from original version of Harvard Medical School (Center for Noninvasive Brain Stimulation).


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Treatment protocol is based on rTMS protocol for mood disorder in Prof. Alvaro Pascual-Leone's laboratory (Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School). Stimulus intensity is 90-100% resting motor threshold (RMT) with total number of pulse of 1000 per session. For stimulus site and frequency, 20Hz rTMS is applied to left Dorsolateral Prefrontal Cortex (DLPFC) and 1Hz rTMS is applied to right DLPFC. Either way is selected for a subject. Amount of time required is 15 minutes to 25 minutes per each rTMS session. To monitor stimulation site on cortex precisely, we employ a non-invasive navigation system using ultrasound and high-resolution MRI data, which is acquired at radiology department, Kanagawa Cardiovascular and Respiratory Center. Basically, rTMS session is performed once per day and 5 days per week. Total number of rTMS sessions is 10-20 sessions (2-4 weeks).

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Inclusion criteria for this clinical study are 1) an inpatient at Kinkou hospital, Kanagawa Psychiatric Center, 2) psychiatric diagnosis of mood disorder (or vascular depression), and 3) an informed consent obtained from a subject. Targetted clinical conditions are major depressive episodes in monopolar and bipolar disorders and vascular depresion which is characterized by prefrontal hypofunction such as hypobulia.

Key exclusion criteria

Exclusion criteria for this clinical study are 1) absolute and relative contraindications of rTMS, and 2) lack of an informed consent. The absolute contraindications of rTMS are any magnetic material in subject's head and implanted medical devices such as cardiac pacemakers. The relative contraindications are medical histories of epilepsy or serious head injury and current status of pregnancy.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Motoaki Nakamura

Organization

Kinkou Hospital, Kanagawa Psychiatric Center

Division name

Department of Psychiatry

Zip code


Address

2-5-1, Serigaya, Kounan-ku, Yokohama, Kanagawa, Japan

TEL

045-822-0241

Email



Public contact

Name of contact person

1st name
Middle name
Last name Motoaki Nakamura

Organization

Kinkou Hospital, Kanagawa Psychiatric Center

Division name

Department of Psychiatry

Zip code


Address

2-5-1, Serigaya, Kounan-ku, Yokohama, Kanagawa, Japan

TEL

045-822-0241

Homepage URL

http://www.kinkou.org/

Email

motoaki@motoaki.com


Sponsor or person

Institute

Kinkou Hospital, Kanagawa Psychiatric Center

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

2008 Year 06 Month 12 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2008 Year 05 Month 07 Day

Date of IRB


Anticipated trial start date

2009 Year 01 Month 01 Day

Last follow-up date

2012 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2012 Year 05 Month 01 Day

Date analysis concluded

2012 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 06 Month 11 Day

Last modified on

2012 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001442


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name