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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001185
Receipt No. 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

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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
Institute Kinkou Hospital, Kanagawa Psychiatric Center
Institute
Department

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
URL(English) https://upload.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


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