How can we apply EEG neurofeedback (feeding back information on how strong brain regions are connected) to therapy for schizophrenia?

JRCT ID: jRCTs052230030

Registered date:30/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Schizophrenia and other psychotic disorder or schizophrenia spectrum disorder
• Date of first enrollment: 08/09/2023
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Neurofeedback training group:
Subjects perform EEG measurement imaging outside the MRI scanner, and their performance according to the brain activity pattern at that time is sequentially presented on a screen in front of them in real time. Participants are asked to improve their performance as much as possible. During training, subjects wear an EEG cap.
Sham training group:
Random task performance independent of the subject's brain activity is presented. During training, subjects wear an EEG cap.
Schedule:
Such neurofeedback training will be given once a day (1-2 hours per session) for 5 sessions over a period of 1-2 weeks. Clinical evaluation will be conducted before the first session and after the last session. Follow-up evaluations will be performed about 1 and/or 2-3 months after the last implementation.

Outcome(s)

• Primary Outcome: Brief Assessment of Cognition in Schizophrenia Japanese version (BACS-J)

Secondary Outcome

Efficacy:
- Cambridge Neuropsychological Test Automated Battery (CANTAB)
- Brief Evaluation of Psychosis Symptom Domains (BE-PSD)
- Schizophrenia Cognition Rating Scale, Japanese version (SCoRS-J)
- Specific Levels of Functioning Assessment, Japanese version (SLOF-J)
- Japanese version of the Schizophrenia Quality of Life Scale (JSQLS)
- Cognitive functions (such as N-back test)
- fMRI/EEG data
- Beck depression Inventory (BDI-2)
- Snaith-Hamilton Pleasure Scale, Japanese version (SHAPS)
- Apathy Scale
- fMRI/EEG data
Safety:
- Adverse events
Other:
- Japanese Adult Reading Test (JART25)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 55age 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-5V. For schizoaffective disorder, the patient must have stable mood symptoms with mood stabilizers.
3. Patients in a stable condition.
4. Participants need to have normal or corrected visual activity.
5. Age at the time of enrolment need to be over 20 years old and under 55 years old.
6. 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
- Learning disorders
- Severe heart disease
- Major depressive disorder
- Bipolar disorder
9. One having past history below,
- Seizure or other neurological disease
- Substance related disorders
- Learning disorders
- Severe heart disease
- Brain injury with loss of consciousness
10. Female having possibility of pregnancy. Female having breast-feeding. Women who do not consent to contraception during the study.
11. One having treatment with drugs known to affect cognitive function such as methamphetamine, etc. (except for anticholinergics and benzodiazepines).
12. Patients in an unstable condition.
13. Other patients who will have difficulty in completing the clinical research, patients who may suffer disadvantages due to participation in the clinical research, or patients whose safety during the clinical period will be difficult to ensure.
14. Previous neurofeedback training, if any, must be no more than one year since the last time.

Related Information

• Primary Sponsor: Yoshihara Yujiro
• Source(s) of Monetary Support: SHIONOGI &amp; CO., LTD.,XNef, Inc.,Advanced Telecommunications Research Institute International (ATR)