The study on the efficacy and the mechanism of repetitive transcranial magnetic stimulation (rTMS) for mood disorders

JRCT ID: jRCTs072180045

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Major depression, bipolar disorder
• Date of first enrollment: 23/07/2013
• Target sample size: 50
• Study type: Interventional
• Intervention(s): rTMS 5 session a week, 30 trains for 6 weeks in total. Cerebrospinal fluid test is performed before and after rTMS.

Outcome(s)

• Primary Outcome: The efficacy of rTMS for patients with refractory mood disorders
• Secondary Outcome: The changes of BDI , biomarkers in cerebrospinal fluid, blood and saliva, fractional anisotropy value, cerebral blood flow rate, cerebral cortex blood flow and oxygen consumption, frontal lobe function, electroencephalogram and their correlation.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1.Patients with major depression or bipolar disorders who were ineffective for the treatment of more than one antidepressants
2.Written informed consent

• Exclude criteria: Absolute contraindications are patients with metals in the brain, patients with intracardiac catheters, patients with high intracardiac pressure. Relative contraindications are epilepsy patients, patients with a history of intracranial lesions, oral history of drugs that reduce convulsion threshold, sleep deprivation, alcohol dependence, pregnant women, children, patients with severe heart disease. Regarding cerebrospinal fluid examination, patients with high risk such as bleeding tendency, heparin use, anesthesia allergy, cerebral hypertension etc., or patients judged inappropriate by the psychiatrist.

Related Information

• Primary Sponsor: Tateishi Hiroshi
• Source(s) of Monetary Support: Department of Pschiatry, Faculty of Medicine, Saga University, Japan Society for the Promotion of Science