Red Light Therapy Device for Brain

1. 1050nm wavelength LED

2. Frequency range adjustable from 1 to 20,000 Hz

3. Default frequency setting is 30Hz. Frequency is not displayed but can be changed with buttons.

4. Duration: can be adjusted from 0 to 30 minutes

5. LED intensity adjustable to four levels: 25%, 50%, 75%, or 100%

6. Includes wireless remote control

7. Total maximum power output: 16W

8. Maximum power output per LED: 50mW

9. Can be operated manually or with a remote control

11. The helmet has 12 regions, each with adjustable power intensity, frequency, and time settings.

12. Also includes nasal and ear laser applicators (controlled by remote), improving treatment efficiency.

Applying light directly to the scalp, allowing photons to penetrate the skull and reach brain tissues. Specific wavelengths, usually in the near-infrared (1050nm), are chosen for their deeper penetration capabilities.

Reduction of Oxidative Stress: PBM reduces oxidative stress by enhancing the activity of antioxidant enzymes. Oxidative stress is a major factor in the degeneration of dopaminergic neurons in Parkinson's disease.

Neuroprotection and Neurogenesis: Neuroprotection: PBM can protect neurons from apoptosis (cell death) by reducing inflammation and preventing the accumulation of toxic proteins, such as alpha-synuclein, which are associated with Parkinson's diseases.

Neurogenesis: PBM has been shown to promote the growth of new neurons and the repair of existing neuronal circuits, which can help in restoring lost functions.

Cytokine Modulation: PBM reduces the levels of pro-inflammatory cytokines and increases anti-inflammatory cytokines. Inflammation in the brain, particularly in the substantia nigra, contributes to the progression of Parkinson's disease.

Microglial Activation: PBM can modulate the activity of microglia (the brain's immune cells), reducing their detrimental overactivation that contributes to neuronal damage.

Enhanced Blood Flow: PBM improves blood flow and oxygenation in the brain, ensuring that neurons receive the nutrients and oxygen they need to function optimally.

Vascular Function: PBM supports the health of the vascular system in the brain, which can be compromised in Parkinson's disease.

Methods

In this double-blind, randomized, sham-controlled feasibility trial, participants aged 59–85 with idiopathic Parkinson's disease were treated with a transcranial photobiomodulation (tPBM) helmet for 12 weeks, totaling 72 sessions of either active or sham treatment (stage 1). The treatment was administered at home, monitored via internet video conferencing (Zoom). After the initial 12 weeks, those who received active treatment had no treatment for another 12 weeks (active-to-no-treatment group), while those initially receiving sham treatment switched to 12 weeks of active treatment (sham-to-active group) if they chose to continue (stage 2). The active helmet delivered red and infrared light to the head for 24 minutes, six days per week. Primary endpoints included safety and motor function, assessed by the modified Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III)-motor scale.



Findings

From December 6, 2021, to August 12, 2022, 20 participants were randomly assigned to either group (10 females and 10 males per group). All participants in the active group and 18 in the sham group completed the 12-week treatment. Fourteen participants in the sham group opted to switch to active treatment, and 12 completed the 12-week active treatment. The treatment was well-tolerated and feasible, with only minor, temporary adverse events. Among the nine identified suspected adverse events, two minor reactions were potentially device-related during the active treatment phase in the sham-to-active group. One participant experienced temporary leg weakness, and another reported decreased fine motor function in the right hand; both continued in the trial. The mean modified MDS-UPDRS-III scores for the sham-to-active group at baseline, after 12 weeks of sham treatment, and after 12 weeks of active treatment were 26.8 (sd 14.6), 20.4 (sd 12.8), and 12.2 (sd 8.9), respectively. For the active-to-no-treatment group, these values were 21.3 (sd 9.4), 16.5 (sd 9.4), and 15.3 (sd 10.8), respectively. There were no significant differences between the groups at any assessment point. The mean differences between groups at baseline were 5.5 (95% CI −2.4 to 13.4), after stage 1 were 3.9 (95% CI −3.5 to 11.3), and after stage 2 were −3.1 (95% CI 2.7 to −10.6).



Conclusion

Our findings contribute to the growing evidence that tPBM is a safe, tolerable, and feasible non-pharmaceutical adjunct therapy for Parkinson's disease. Although further research is necessary, our results lay the groundwork for a larger, adequately powered randomized placebo-controlled clinical trial.

Our study adds to the body of evidence suggesting that transcranial PBM is both a safe and feasible adjunctive treatment for Parkinson's disease. The observed improvements in motor signs, combined with data from previous clinical trials and animal studies, highlight the potential of tPBM as an effective adjunct treatment alongside traditional dopamine medications. Further investigation is warranted, and this study sets the stage for a well-powered randomized placebo-controlled clinical trial in the future.