white paper

A Multi-Modal Integrative Neuro-Rehabilitation Protocol for Severe Neuro-Psychiatric Decompensation in Adult Autism Spectrum Disorder: A Case Study

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Abstract

Background & Hypothesis
Adult Autism Spectrum Disorder (ASD) presenting with severe, recurrent neuro-psychiatric decompensation often involves complex multi-system physiological impairments—including cellular membrane lipid dysregulation, altered cranial-dural biomechanics, compromised cerebrospinal fluid dynamics, and impaired cerebral perfusion. We hypothesized that targeted biochemical optimization combined with structural neuro-biomechanical correction and non-invasive neuromodulation would synergistically resolve underlying physiological drivers of severe neuro-psychiatric distress where conventional mono-target psychiatric and behavioral interventions had failed.
Objective & Rationale
The objective was to test whether addressing multi-system biochemical, neuro-structural, and metabolic dysfunctions simultaneously could restore neurological stability and functional independence in a high-acuity adult ASD case. A structured 60-day multi-modal protocol was designed to evaluate three targeted mechanisms: (1) Plasmalogen Precursor Administration to restore cellular membrane lipid homeostasis and peroxisomal function; (2) Upper Cervical Adjustments & Endonasal Cranial Release (ECR) to correct cranial-dural mechanics, optimize cerebrospinal fluid (CSF) flow, and alleviate neuro-spinal strain; and (3) Transcranial Photobiomodulation (tPBM) to stimulate mitochondrial respiration and enhance regional cerebral blood flow.
Results & Conclusion
Following the multi-modal protocol, the patient demonstrated rapid emotional stabilization, complete cessation of self-injurious behaviors, full resolution of tactile hypersensitivity, and marked recovery in adaptive and executive functions, ultimately progressing to daily self-sufficiency and vocational reintegration. These outcomes support the hypothesis that multi-modal targeted interventions addressing biochemical, structural, and metabolic root causes can offer significant therapeutic synergy for adult ASD patients recovering from severe neuro-psychiatric decompensation.

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white paper

A multimodal evaluation of transcranial photobiomodulation in mild cognitive impairment: Cognitive, metabolic, and neuroimaging outcomes of a pilot randomized controlled trial

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Abstract

Background

Mild cognitive impairment (MCI), a prodromal stage of Alzheimer’s disease and related dementias (ADRD), represents a critical window for intervention. Although mitochondrial dysfunction is increasingly implicated in neurodegeneration, most therapies target downstream protein aggregation. Transcranial photobiomodulation (tPBM) delivers near-infrared light to enhance mitochondrial respiration.
Objective
We hypothesized that tPBM in MCI would be safe, feasible, and associated with improvements in cognition, mitochondrial function, and default mode network (DMN) functional connectivity (FC).
Methods
We conducted a single-blind, randomized, sham-controlled pilot trial (NCT05563298) in adults ≥50 years with MCI. Twenty participants were randomized 1:1 to active or sham devices. Active devices delivered pulsed 810-nm light for 20 min per session; shams emitted light for 2 seconds. Stimulation targeted DMN hubs and the olfactory bulb. Participants self-administered treatment at home six days per week for six weeks.
Results
Adherence was high (active 96.9%; sham 94.2%). Adverse events (AEs) were reported by 10 of 20 participants (4 active, 6 sham). No serious AEs occurred. Compared with sham, active tPBM produced greater improvement in global cognition (Mini-Mental State Examination; p = 0.03, d = 1.05) and episodic memory (California Verbal Learning Test-II long-delay recognition; p = 0.02, d = 1.09). Serum pyruvate and lactate increased with a reduced lactate-to-pyruvate (L/P) ratio (p = 0.007, d = -1.37). DMN FC increased (p = 0.014, d = 1.25), and plasma IL-6 declined (p = 0.02, r = -0.52).
Conclusions
Home-based tPBM was safe, well tolerated, and feasible, with high adherence and mild AEs. Cognitive, metabolic, and network-level findings are consistent with enhanced mitochondrial efficiency and anti-inflammatory effects. These results support larger, double-blind, multicenter trials to evaluate tPBM as a mitochondria-targeted therapy in early ADRD.

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white paper

Clinical Stability and Functional Improvement in Amyotrophic Lateral Sclerosis Following Extended Brain-Gut Photobiomodulation Therapy: A Case Report

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Abstract

Background

Amyotrophic lateral sclerosis (ALS) is a form of motor neuron disease (MND), a progressive neurodegenerative disorder with limited therapeutic options. Photobiomodulation (PBM) therapy has demonstrated neuroprotective properties in preclinical models, yet clinical evidence in human ALS patients remains sparse.

Methods

We present a 39-year-old male with bulbar-onset, upper motor neuron-predominant ALS who commenced twice-daily CeraThrive (Light Tree Ventures, Den Haag, Netherlands) red and near-infrared light therapy (630-1070 nm, 40 Hz) in January 2023, applied to the motor cortex, anterior neck, and abdomen.

Results

The clinician-administered ALSFRS-R score improved from 32 at baseline (February 2020) to 37 (February 2025), representing a cumulative 5-point improvement. Peripheral oxygen saturation also improved, rising from 89% (February 2020) to 96% (February 2026).The patient reported subjective improvements in ambulation, spasticity, swallowing, and general wellbeing.

Conclusions

While the case report methodology has limitations, functional improvement in a disease characterised by rapid progressive decline provides rationale for controlled clinical trials investigating PBM in ALS.

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Modulating cerebrospinal fluid dynamics using pulsed photobiomodulation

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Abstract

Introduction: The use of photobiomodulation (PBM) to enhance brain health, specifically glymphatic drainage and thus neurotoxic waste clearance, may make it a promising therapeutic tool against neurodegenerative diseases such as Alzheimer’s disease.
Material and method: This study investigates whether PBM can modulate cerebrospinal fluid (CSF) flow in 45 healthy young adults. We conducted forehead transcranial PBM (tPBM) and intranasal PBM (iPBM) at the nostril, and measured CSF dynamics using blood-oxygenation level-dependent (BOLD) functional MRI (fMRI). Our data demonstrates 4 min of PBM-induced increases in CSF flow.
Conclusion and result: Our data shows that (1) even a short PBM of 4 min can induce a change in CSF dynamics, in the form of an immediate increase in intracranial CSF volume and a reduction in CSF inflow; (2) skin melanin had a significant effect on the CSF response in tPBM, with lighter skin associated with higher responses; (3) both iPBM and tPBM displayed a dose-dependent effect on CSF dynamics in terms of a wavelength-irradiance interaction; (4) intranasal PBM (iPBM) can be used to produce a significant change in CSF dynamics that is equivalent to forehead transcranial PBM (tPBM) with a small fraction of the irradiance. The most likely explanation for the observed fMRI signal changes in CSF regions of interest for both tPBM and iPBM is an increased CSF outflow pressure due to PBM-induced vasodilation that transiently increases intracranial CSF volume and reduces net CSF inflow.
Impact: This study establishes that PBM can modulate CSF flow in the healthy human brain in real time. This study also suggests that iPBM may be more efficient in CSF modulation due to the proximity to the olfactory system and the lack of melanin dependence. The influence of melanin on tPBM, the feasibility of iPBM and the dose dependence of both will require further investigation in healthy and patient populations.
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white paper

Wearable, self-administered transcranial photobiomodulation for major depressive disorder and sleep: A randomized, double blind, sham-controlled trial

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Abstract

Background

Device-based treatments exist in psychiatry for decades, but are usually operated by clinicians and require multiple office visits. Near-infrared transcranial photobiomodulation (tPBM) is a safe neurostimulation modality with potential antidepressant and hypnotic effects. We investigated the feasibility and efficacy of adjunctive tPBM treatment, self-administered by a wearable headband.

Methods

We randomized 48 outpatients with major depressive disorder (MDD) into tPBM or sham with 1:1 ratio. All participants were advised to receive the device-based intervention for at least 20 min daily at their preferred time and place for 8 weeks. The compliance and adverse events were monitored throughout the trial. The Hamilton Depression Rating Scale (HAMsingle bondD), Beck’s Depression Inventory (BDI) and Pittsburgh Sleep Quality Index (PSQI) were used to evaluate the symptoms from baseline until week-12.

Results

Participants reported this self-administered intervention well-tolerated. Treatment compliance was equally good between various group-comparisons, and the adverse effects were minimal and transient. Post-treatment, the HAMD and BDI scores of patients in both tPBM group and sham group significantly decreased compared to baseline, with no between-group difference. However, a significant PSQI score reduction was only found in tPBM group from week-2 onward compared with baseline, with significant between-group difference lasting until week-12 (F1,46 = 6.16, p = 0.017).

Limitations.
This smaller sample size and short treatment and follow-up durations.

Conclusions

Self-administered wearable tPBM appears to be a feasible and well-tolerated in MDD patients. The low-level dosimetry appeared insufficient to produce an antidepressant effect but effective in improving sleep quality. Further studies should investigate different dosimetry and intervention time.

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white paper

Transcranial photobiomodulation for reducing symptoms of autism spectrum disorder and modulating brain electrophysiology in children aged 2–7: an open label study

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Abstract

Background

Small pilot studies have indicated that transcranial photobiomodulation (tPBM) may help alleviate symptoms of neurological conditions like depression, traumatic brain injury and Autism Spectrum Disorder (ASD).

Objective

To examine the effect of tPBM on the behavioral symptoms of ASD and brain electrophysiology in children aged 2–7.

Methods

We conducted an open label, one-arm study with 23 participants, aged 2–7, previously diagnosed with ASD. We delivered non-invasively to all participants pulses of near-infrared light (wavelength 850 nm, pulse 40 Hz) to cortical nodes of Default Mode Network, Broca and Wernicke areas, and occipital lobe of the brain, twice weekly for 10 weeks. The tPBM was delivered using an investigational medical device designed for this purpose. Changes in ASD symptoms were measured using pre- and post-intervention scores on the Childhood Autism Rating Scale (CARS-2, 2nd Edition). We collected electroencephalogram (EEG) data after each treatment session from all children who tolerated wearing the EEG cap to monitor changes in brain activity.

Results

The intervention resulted in a significant 7-point reduction in average CARS-2 scores (t = 10.23, p < .0001), along with decreased delta power and increased gamma and beta power in EEG readings. The increase in gamma power was statistically significant [t(14) = 2.30, p = 0.047]. Changes in EEG power were significantly correlated with the number of sessions (delta: r(192) = −0.18, p = .013; gamma: r(192) = .19, p = .007; beta: r(192) = .15, p = .04). Improvements in CARS-2 scores were negatively correlated with changes in delta and beta power (delta: r(15) = −.59, p = .020; beta: r(15) = −.54, p = .037). No moderate or severe side effects were reported.

Conclusion

This study supports the potential of tPBM as a safe and effective treatment for ASD, and it suggests that EEG measurements may serve as a useful biomarker for future research.

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white paper

Modifying Alzheimer’s Disease Pathophysiology with Photobiomodulation: Model, Evidence, and Future with EEG-Guided Intervention

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Abstract:

Alzheimer’s disease (AD) is a major public health problem all over the world. Therapeutic strategies have been explored for several decades, but no curative treatment has been developed (1). Although the FDA has recently approved lecanemab (Leqembi) and donanemab (Kisunla) for treating cognitive decline in early Alzheimer’s disease, their efficacy is modest, with potential side effects like amyloid-related imaging abnormalities (ARIA), and their long-term impact on disease progression remains uncertain, particularly in advanced stages (2, 3). However, these drugs represent a significant advancement by objectively reducing amyloid beta (Aβ) markers, which purportedly slow disease progression in patients with early-stage AD, marking an important first step toward more effective therapies.

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white paper

Unleashing light’s healing power: an overview of photobiomodulation for Alzheimer’s treatment

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Abstract:

Aim: Photobiomodulation involves the use of low-level light therapy or near-infrared light therapy found to be useful in the treatment of a wide range of neurological diseases.

Objective: The aim is to review the mechanism and clinical applications of photobiomodulation therapy (PBMT) in managing Alzheimer’s disease. Methods: To ensure that the consensus statement accurately reflects both the experts’ viewpoint and the most recent developments in the field, the expert opinions were recorded and thoroughly reviewed.

Results: PBMT elicits reduction of beta-amyloid plaque, restoration of mitochondrial function, anti-inflammatory and antioxidant properties with a stimulation in ATP synthesis.

Conclusion: The PBMT could be helpful in patients non-responsive to traditional pharmacological therapy providing significant aid in the management of Alzheimer’s disease when introduced into the medical field.

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white paper

Transcranial photobiomodulation in children aged 2–6 years: a randomized sham-controlled clinical trial assessing safety, efficacy, and impact on autism spectrum disorder symptoms and brain electrophysiology

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Abstract

Background

Small pilot studies have suggested that transcranial photobiomodulation (tPBM) could help reduce symptoms of neurological conditions, such as depression, traumatic brain injury, and autism spectrum disorder (ASD).

Objective

To examine the impact of tPBM on the symptoms of ASD in children aged two to six years.

Method

We conducted a randomized, sham-controlled clinical trial involving thirty children aged two to six years with a prior diagnosis of ASD. We delivered pulses of near-infrared light (40 Hz, 850 nm) noninvasively to selected brain areas twice a week for eight weeks, using an investigational medical device designed for this purpose (Cognilum™, JelikaLite Corp., New York, United States). We used the Childhood Autism Rating Scale (CARS, 2nd Edition) to assess and compare the ASD symptoms of participants before and after the treatment course. We collected electroencephalogram (EEG) data during each session from those participants who tolerated wearing the EEG cap.

Results

The difference in the change in CARS scores between the two groups was 7.23 (95% CI 2.357 to 12.107, p = 0.011). Seventeen of the thirty participants completed at least two EEGs and time-dependent trends were detected. In addition, an interaction between Active versus Sham and Scaled Time was observed in delta power (Coefficient = 7.521, 95% CI -0.517 to 15.559, p = 0.07) and theta power (Coefficient = −8.287, 95% CI -17.199 to 0.626, p = 0.07), indicating a potential trend towards a greater reduction in delta power and an increase in theta power over time with treatment in the Active group, compared to the Sham group. Furthermore, there was a significant difference in the condition (Treatment vs. Sham) in the power of theta waves (net_theta) (Coefficient = 9.547, 95% CI 0.027 to 19.067, p = 0.049). No moderate or severe side effects or adverse effects were reported or observed during the trial.

Conclusion

These results indicate that tPBM may be a safe and effective treatment for ASD and should be studied in more depth in larger studies.

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