Schizophrenia Schizophrenia
Conditions
Interventions
LED Specications:
Light source, LED module: 810 nm LED (100 mW/cm2 x 3 & 75 mW/cm2 x 1)
Light source, nasal applicator: 810 nm LED (25 mW/cm2)
Pulse rate: 10 Hz (Alpha), 40 Hz (Gamma)
Duty cycle: 50 %
tPBM
Sponsors
Sumiyoshi Tomiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Meeting DSM-5 criteria for schizophrenia (2)Being 18 through 70 years old (3)Being able to understand the objective and content of the study and provide consent to participate (4)Scoring less than 0.5SD on the Rey Auditory Verbal Learning Test and Digit Symbol cordings at baseline
Exclusion criteria
Exclusion criteria: (1)Current or past history of traumatic brain injury, severe brain lesion or epilepsy (2)Alcohol or substance disorder within the past 12 months (3) Diagnosed with Intellectual Disability (4)Contraindicated to electroconvulsive therapy and clinically contraindicated by tPBM (e.g., history of brain traumatic injury) (5)Treated with cognitive rehabilitation therapy within the past one month (6)Being judged inappropriate to participate for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmation of the presence and frequency of adverse events (based on MedDRA Version 26.0 and the Common Terminology Criteria for Adverse Events) at baseline, 1 week, 3 months, and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Based on data obtained at baseline, 3 months, and 6 months, the following will be evaluated Change in MCCB total score (T-score) Change in MADRS score (a clinician-rated scale for depressive symptoms) Change in SLOF score (a scale that evaluates social functioning based on objective or subjective assessment) Change in SCoRS score (a cognitive function assessment scale based on interviews) Change in SANS score (a scale for evaluating negative symptoms of schizophrenia based on interviews) Change in SAPS score (a scale for evaluating positive symptoms of schizophrenia based on interviews) Change in SWLS score (a self-reported scalefor subjective well-being) Change in the amplitude of mismatch negativity(MMN), an event-related potential Change in oxy-hemoglobins throughout verbal fluency task between | — |
Contacts
Public ContactRisa Yamada
National Center of Neurology and Psychiatry
Outcome results
None listed