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A semi-crossover open trial of combined therapy of fMRI neurofeedback and repetitive transcranial magnetic stimulation (rTMS) for affective disorders.

A semi-crossover open trial of combined therapy of fMRI neurofeedback and repetitive transcranial magnetic stimulation (rTMS) for affective disorders. - A semi-crossover open trial of combined therapy of fMRI neurofeedback and repetitive transcranial magnetic stimulation (rTMS) for affective disorders.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013272
Enrollment
30
Registered
2014-02-25
Start date
2014-03-14
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

Major depressive disorder (Monopolar depression) and bipolar disorder(Bipolar I disorder and bipolar II disorder)

Interventions

fMRI neurofeedback Connectivity-based neurofeedback using a 3T fMRI apparatus Navigation-guided high-frequency rTMS TMS coil: air-cooled figure-of-eight coil site: left dorsolateral prefrontal

Sponsors

Kyoto University Graduate School of Medicine
Lead Sponsor
Advanced Telecommunications Research Institute International(ATR)
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. DSM-IV-TR diagnosis of major depressive disorder or bipolar disorder(BPI or II) 2. Current diagnosis of major depressive episode 3. Normal visual acuity 4. Aged 20-75 years-old, outpatients, self-sustained ADL 5. Capability of informed consent

Exclusion criteria

Exclusion criteria: 1. Implanted cardiac pacemaker 2. Surgical aneurysm clips 3. Neurostimulator 4. Implanted pumps 5. Metal fragments in body/eyes 6. Tattoos or permanent eyeliner (if ink contains metallic specks) 7. Treatment history of ECT 8. Diagnosis of neurological disorders (including epilepsy), substance dependence, or significant cardiac disease 9. History of neurological disorders (including epilepsy), substance dependence, or head injury with loss of consciousness

Design outcomes

Primary

MeasureTime frame
1) Hamilton Depression Rating Scale (Ham-D) 17items and 24items 2) Beck Depression Inventry II (BDI-II) 3) Self-rating Depression Scale (SDS) 4) rTMS side effects questionnaire, which was translated in Japanese from original version of Center for Noninvasive Brain Stimulation, Harvard Medical School.: evaluated every rTMS session

Secondary

MeasureTime frame
5) State-Trait Anxiety Inventory (STAI) 6) Bipolar Spectrum Diganostic Scale (BSDS) 7) Neuropsychological Tests (Emotional "Face-word" Stroop Task, Four-armed Bandit Task)

Countries

Japan

Contacts

Public ContactHidehiko Takahashi

Kyoto University Graduate School of Medicine Department of Psychiatry

hidehiko@kuhp.kyoto-u.ac.jp075-751-3386

Outcome results

None listed

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