The development of treatment using the connectivity neurofeedback for patients with affective disorders

JRCT ID: jRCTs052180169

Registered date:26/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Major depressive disorder and bipolar disorder
• Date of first enrollment: 29/01/2016
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Neuro-feedback: Subjects are asked to manage tasks in MRI/EEG scanner, while fMRI/EEG data are collected. Marks for the task are presented to the subject at the end of each block. The marks are according to correlation or patterns of brain activity measured. Subjects are asked to improve the marks as much as possible.
Schedule: Subjects undergo neuro-feedback sessions (1-2 hours at a time) once in a day, for 20 days maximum, within a period of 1-8 weeks.

Outcome(s)

Primary Outcome

fMRI/EEG data
Severity of depressive symptoms

Secondary Outcome

Severity of other mental symptoms
Cognitive function

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1) Normal visual acuity
2) Aged 20-50 years-old
3) Capability of informed consent
4) DSM-IV-TR or DSM-5 diagnosis of major depressive disorder or bipolar disorder(BPDor II)
5) Current diagnosis of major depressive episode

Exclude 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

Related Information

• Primary Sponsor: Yoshihara Yujiro
• Source(s) of Monetary Support: Strategic Research Program for Brain Sciences,Strategic Research Program for Brain Sciences