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An exploratory study for the development of novel individually optimized treatment using transcranial magnetic stimulation (TMS) for patients with mood disorders

An exploratory study for the development of novel individually optimized treatment using transcranial magnetic stimulation (TMS) for patients with mood disorders - The development of novel treatment using transcranial magnetic stimulation for patients with mood disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019481
Enrollment
70
Registered
2015-10-23
Start date
2015-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mood disorders (major depressive disorder and bipolar disorder) and healthy volunteers

Interventions

For depressive patients, repetitive TMS will be applied with the following parameters below. Target location: left dorsolateral prefrontal cortex localized by a spatial navigation system Stimulation
s resting motor threshold Number of pulses: 2000-3000 pulses/day Number of total sessions: 20-30 sessions For healthy-control individuals, causally examine regionally interconnected brain regions

Sponsors

Department of Psychiatry and Neurosciences, Graduate school of Biomedical and Health Sciences, Hiroshima University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: For patients/clients 1) Aged 20-80 years old 2) Being diagnosed as major depressive disorder or bipolar disorder (Type I, Type II) according to DSM-IV-TR or DSM-5 3) Current diagnosis of major depressive episode 4) Present treatment-resistance (scores with 14 points or above out of 17 items on the Hamilton Rating Scale for Depression even after >=4 weeks of treatment with sufficient amount of more than1 anti-depressant) or low treatment-tolerance (insufficient administration due to side-effects while taking more than 1 anti-depressant) 5) Satisfactory informed consent obtained from participant him/herself For healthy control 1) Aged 20-80 years old 2) No history of any psychiatric disorders 3) Not having current serious medical illness 4) Satisfactory informed consent obtained from the participant him/herself

Exclusion criteria

Exclusion criteria: Rejection criteria common to both patients and healthy controls 1) Decisionally impaired individuals who has diminished capacity to understand the aim of the research 2) Physically impaired individuals who are not able to complete the experiments 3) Subjects who are contraindicated for the use of TMS and MRI Having an implanted heart pace-maker Having implanted cerebral (arteries) clips Having implanted neural/nerve stimulators Having implanted pumps Having work experience in a metal industry or possibility of metal residues remaining in the body Having metal-tattoos (including tattooed eye-lining) Being pregnant, or having possibility of being pregnant 4) Subjects who are contraindicated for the use of TMS Personal history of seizure disorder such as epileptic disorder 5) Any individuals judged as inappropriate for the experiment by the principal investigator or a collaborating researcher

Design outcomes

Primary

MeasureTime frame
Using psychological assessments and neuroimaging techniques, we evaluate psychological and neural changes in depression-related symptoms, immediately after the intervention, one week later, one month later, and again six months later.

Countries

Japan

Contacts

Public ContactGo Okada

IGraduate school of Biomedical and Health Sciences, Hiroshima University Department of Psychiatry and Neurosciences

goookada@hiroshima-u.ac.jp082-257-5814

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026