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

UMIN ID: UMIN000001185

Registered date:12/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Mood Disorder Vascular Depression
• Date of first enrollment: 2009/01/01
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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).

Outcome(s)

• Primary Outcome: 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.
• Secondary Outcome: 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).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Kinkou Hospital, Kanagawa Psychiatric Center
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology