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

Phase 1

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

• Registration Number: JPRN-UMIN000013272
• Lead Sponsor: Kyoto University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-25
• Study Completion: 2014-09-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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