A research for clinical application of real-time functional magnetic resonance imaging neurofeedback for treatment of schizophrenia

JRCT ID: jRCTs052180168

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Schizophrenia
• Date of first enrollment: 21/08/2017
• Target sample size: 25
• Study type: Interventional
• Intervention(s): One NFB session in fMRI scanner will be conducted once a day, and 5 days a week. After 5-10 sessions (in one or 2 weeks), symptoms and conditions of participants will be evaluated.

Outcome(s)

• Primary Outcome: Positive And Negative Symptoms Scale (PANSS)

Secondary Outcome

Brief Assessment of Cognition in Schizophrenia (BACS)
Cambridge Neuropsychological Test Automated Battery (CANTAB)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Both

Include criteria

1. Participants need to be outpatients of department of psychiatry, Kyoto University.
2. Participants need to be diagnosed as schizophrenia and other psychotic disorders, or schizophrenia spectrum in DSM-IV-TR or DSM-V.
3. Participants need to have normal or corrected visual acuity.
4. Age at the time of enrolment need to be over 20 years old and under 50 years old.
5. Participants need to give informed consent by themselves on paper.

Exclude criteria

1. User of cardiac pacemaker
2. User of brain vascular clip
3. User of electric stimulator for neurons
4. User of implanted pump in body
5. One having remaining metallic piece in one's body
6. One having tattoo
7. One having treatment with electroconvulsive therapy
8. One having comorbid disorder below,
Seizure or other neurological disease
Substance related disorders
Severe heart disease
9. One having past history below,
Seizure or other neurological disease
Substance related disorders
Brain injury with loss of consciousness
10. Female having possibility of pregnancy. Female having breast-feeding. Male of Female not using birth control during research
11. One having been judged as inappropriate for research by researcher and doctors.

Related Information

• Primary Sponsor: Yujiro Yoshihara
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology (MEXT),Japan Agency of Medical Research and Development,National Institute of Information and Communications Technology