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A Double-Blind Randomized Controlled Trial of Functional Connectivity Neurofeedback Therapy for Schizophrenia

A Double-Blind Randomized Controlled Trial of Functional Connectivity Neurofeedback Therapy for Schizophrenia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032250363
Enrollment
35
Registered
2025-09-16
Start date
2025-09-16
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

Schizophrenia

Interventions

The first intervention consists of one neurofeedback (NF) session in the fMRI scanner per day, each lasting approximately 45 minutes. These sessions will be conducted on three separate days within a t

Sponsors

Takahashi Hidehiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The participant must be receiving outpatient psychiatric care at one of the following institutions: Institute of Science Tokyo University Hospital, Showa University Karasuyama Hospital, Hiroshima University Hospital, or Kyoto University Hospital. 2. The participant must have a diagnosis of schizophrenia, another psychotic disorder, or a schizophrenia spectrum disorder according to the DSM-IV-TR, DSM-5, or DSM-5-TR criteria. 3. The participant must have normal corrected visual acuity. 4. The participant must be between 20 and 60 years of age at enrollment. 5. The participant must provide written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: (i) Individuals with a pacemaker. (ii) Individuals with cerebrovascular clips. (iii) Individuals with electrical nerve stimulators. (iv) Individuals with an implantable pump. (v) Individuals who have metal fragments in their body (including cases where their presence cannot be definitively ruled out by self-report or medical records). (vi) Individuals with tattoos (including tattooed eyeliner, etc.). (vii) Individuals with a history of electroconvulsive therapy (ECT). (viii) Individuals who currently have any of the following conditions: Epilepsy or another neurological disorder Substance dependence Severe heart disease (ix) Individuals who have a past history of any of the following: Epilepsy or another neurological disorder Substance dependence Severe heart disease Drug addiction Head injury with loss of consciousness (x) Women who are pregnant or may become pregnant, women who are breastfeeding, and any individual (male or female) who does not agree to use contraception during the study. (xi) Individuals receiving treatment with drugs known to affect cognitive function (e.g., methamphetamine). Anticholinergics and benzodiazepines are excluded from this restriction. (xii) Individuals who have undergone neurofeedback training within the past year. (xiii) Any other individual deemed unsuitable for safe participation by the principal investigator or attending physician.

Design outcomes

Primary

MeasureTime frame
Positive And Negative Symptoms Scale (PANSS)

Secondary

MeasureTime frame
Brief Assessment of Cognition in Schizophr enia (BACS) Cambridge Neuropsychological Test Automated Battery (CANTAB) OTHERS

Contacts

Public ContactHidehiko Takahashi

Institute of Science Tokyo Hospital

hidepsyc@tmd.ac.jp+81-3-3813-6111

Outcome results

None listed

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