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Crossover study of functional connectivity neurofeedback for depression

A double-blind, randomized, controlled trial of active control crossover design of functional connectivity neurofeedback treatment for depression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062250026
Enrollment
28
Registered
2025-06-27
Start date
2025-06-27
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

depression

Interventions

Sponsors

Okada Go
Lead Sponsor
Aurelio Cortese
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with major depressive (1) Aged 18-60 years old (2)Being diagnosed as depression (currently meeting the criteria for a depressive episode) according to DSM-5 criteria (3)Written consent for participation has been obtained from the participant him/herself

Exclusion criteria

Exclusion criteria: (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 experiment (3) Subjects who are contraindicated for the use of 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 MRI claustrophobia (4)Those who have received NF, mECT, or rTMS within the past 1 year (5)Any individuals judged as inappropriate for the experiment by the principal investigator or a collaborating researcher

Design outcomes

Primary

MeasureTime frame
(1) Change from baseline in symptom A (assessed by HRSD and BDI-II) when neurofeedback targeting functional coupling A (2) Change from baseline in symptom B (assessed by HRSD and BDI-II) when neurofeedback targeting functional coupling B

Secondary

MeasureTime frame
(1) Anxiety symptoms: Change from baseline in anxiety symptoms (assessed by STAI). STAI is a self-administered questionnaire test that measures anxiety by dividing it into two factors: state anxiety and trait anxiety. (2) Rumination symptoms: Change from baseline in rumination symptoms (assessed by RRS). RRS is a self-administered questionnaire test. (3) Cognitive function: Change from baseline in cognitive function (as assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB). CANTAB is a computer-based test battery developed to evaluate cognitive function, and is performed on a touch-panel iPad. (4) Social cognitive function: Changes from the baseline of EBT (Emotion Bias Task). EBT is a computer-based test battery administered using a touch panel mobile device.

Contacts

Public ContactGo Okada

Hiroshima University

goookada@hiroshima-u.ac.jp+81-82-257-5814

Outcome results

None listed

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