Unique ID issued by UMIN | UMIN000001185 |
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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 |
Therapeutic application of the navigation-guided repetitive transcranial magnetic stimulation to mood disorder and vascular depression.
The navigation-guided repetitive transcranial magnetic stimulation.
Therapeutic application of the navigation-guided repetitive transcranial magnetic stimulation to mood disorder and vascular depression.
The navigation-guided repetitive transcranial magnetic stimulation.
Japan |
Mood Disorder
Vascular Depression
Psychiatry |
Others
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II,III
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.
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).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
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).
20 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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.
70
1st name | |
Middle name | |
Last name | Motoaki Nakamura |
Kinkou Hospital, Kanagawa Psychiatric Center
Department of Psychiatry
2-5-1, Serigaya, Kounan-ku, Yokohama, Kanagawa, Japan
045-822-0241
1st name | |
Middle name | |
Last name | Motoaki Nakamura |
Kinkou Hospital, Kanagawa Psychiatric Center
Department of Psychiatry
2-5-1, Serigaya, Kounan-ku, Yokohama, Kanagawa, Japan
045-822-0241
http://www.kinkou.org/
motoaki@motoaki.com
Kinkou Hospital, Kanagawa Psychiatric Center
Ministry of Education, Culture, Sports, Science and Technology
Japan
NO
2008 | Year | 06 | Month | 12 | Day |
Partially published
Completed
2008 | Year | 05 | Month | 07 | Day |
2009 | Year | 01 | Month | 01 | Day |
2012 | Year | 04 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2012 | Year | 10 | Month | 01 | Day |
2008 | Year | 06 | Month | 11 | Day |
2012 | Year | 04 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001442
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