Trial results for a study investigating transcranial photobiomodulation (tPBM) for Bipolar Disorder were posted on ClinicalTrials.gov on 2025-08-28, with 13 participants enrolled.
Background
Bipolar disorder is a mental health condition characterized by significant mood swings, including emotional highs (mania or hypomania) and lows (depression). These fluctuations can severely impact daily life and cognitive functions, such as executive function. Current treatments often involve medication and psychotherapy, but there remains a need for additional therapeutic options. Transcranial light therapy, or transcranial photobiomodulation (tPBM), is an investigational treatment that applies near-infrared light to the forehead to stimulate the brain. This therapy is thought to promote brain metabolism, which may contribute to improving executive function in individuals with bipolar disorder.
Trial design
This completed Phase 2 study enrolled 13 participants with Bipolar Disorder. The trial investigated transcranial photobiomodulation (tPBM), a form of transcranial light therapy. The study aimed to test the effect of tPBM on cerebral blood flow (CBF) and impaired decision making. The analyses conducted included comparisons between active stimulation and sham conditions, as well as between different active stimulation timepoints.
Key results
The trial reported several key measurements and analyses:
- For the outcome “Test the Effect of Transcranial Photobiomodulation (tPBM) on Cerebral Blood Flow (CBF)” in Transcranial Light Therapy Subjects:
- A mean value of 6611.645 A.U. (Standard Deviation 794.5616) was observed.
- Another mean value of 6666.398 A.U. (Standard Deviation 784.01) was observed.
- A third mean value of 6666.398 A.U. (Standard Deviation 784.01) was observed.
- A fourth mean value of 6891.237 A.U. (Standard Deviation 412.7808) was observed.
- For the outcome “Test the Effect of tPBM on Impaired Decision Making” in Subjects:
- A mean value of 3750 units on a scale (Standard Deviation 805.19) was observed.
- Another mean value of 4425 units on a scale (Standard Deviation 448.14) was observed.
- A third mean value of 4512.5 units on a scale (Standard Deviation 586.48) was observed.
- A fourth mean value of 4637.5 units on a scale (Standard Deviation 432.77) was observed.
- A fifth mean value of 762.5 units on a scale (Standard Deviation 228.67) was observed.
- A sixth mean value of 69.75 units on a scale (Standard Deviation 8.77) was observed.
- A seventh mean value of 70.5 units on a scale (Standard Deviation 4.51) was observed.
- An eighth mean value of 71.25 units on a scale (Standard Deviation 8.01) was observed.
Key analyses included:
- A Mean Difference (Final Values) of 54.75 was reported.
- A Percent Difference of 0.85 was calculated between active stimulation and sham. The small sample size did not allow for statistical tests.
- Cohen's d, evaluating the effect size between active and sham stimulation, was 0.07.
- Another Mean Difference (Final Values) of 224.8392 was reported.
- A Percent Difference of 4.35 was calculated between active stimulation timepoints (Day 1 vs Day 5). The small sample size did not allow for statistical tests.
- Cohen's d, evaluating the effect size between active stimulation timepoints (Day 1 vs Day 5), was 0.36.
What this means
The posted results from this Phase 2 trial provide initial data on the effects of transcranial photobiomodulation (tPBM) on cerebral blood flow and impaired decision making in a small cohort of 13 participants with Bipolar Disorder. While specific mean values and standard deviations for various measurements were reported, the analyses indicated relatively small effect sizes, with Cohen's d values of 0.07 and 0.36, and percent differences of 0.85% and 4.35%. The trial noted that the small sample size precluded formal statistical tests. These preliminary findings suggest that tPBM may have a modest impact on the measured parameters, warranting further investigation in larger studies to determine its potential clinical significance for individuals with bipolar disorder.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05408637, titled "Transcranial Photobiomodulation for Executive Function in Bipolar Disorder", were posted on 2025-08-28 on clinicaltrials.gov.