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A trial on the effect of photobiomodulation on cognitive impairment in schizophrenia

Cognitive enhancement by photobiomodulation in schizophrenia

Sumiyoshi Tomiki

National Center of Neurology and Psychiatry

4-1-1, Ogawahigashi, Kodaira, Tokyo 187-0031, Japan.

sumiyot@ncnp.go.jp

Yamada Risa

National Center of Neurology and Psychiatry

4-1-1, Ogawahigashi, Kodaira, Tokyo 187-0031, Japan.

+81-423412711

riyamada@ncnp.go.jp

Recruiting

Mar. 31, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(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

(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

Both

Schizophrenia

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 %
General Specications:
Treatment duration: Automatic shut-o at 20 +/- 0.1 minutes
Low power indicator: < 4.2 V
Power adapter: AC Input: 100-240 V, 0.5 A, 50/60 Hz
DC Output: 5 V, 2.0 A
Frequency: 3 times /week x 12 week
Time: 20 minutes per session

Schizophrenia

tPBM

F2

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.

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

+81-42-341-2712-7828

Mar. 17, 2025

No

none