white paper

Transcranial Photobiomodulation Helmet treating Parkinson’s Disease

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April 13, 2023

Abstract:
Emerging evidence is increasingly supporting the use of transcranial photobiomodulation (tPBM) to improve symptoms of neurodegenerative diseases, including Parkinson’s disease (PD). The objective of this study was to analyse the safety and efficacy of tPBM for PD motor symptoms. The study was a triple blind, randomized placebo-controlled trial with 40 idiopathic PD patients receiving either active tPBM (635 nm plus 810 nm LEDs) or sham tPBM for 24 min per day (56.88J), six days per week, for 12 weeks. The primary outcome measures were treatment safety and a 37-item MDS-UPDRS-III (motor domain) assessed at baseline and 12 weeks. Individual MDS-UPDRS-III items were clustered into sub-score domains (facial, upper-limb, lower-limb, gait, and tremor). The treatment produced no safety concerns or adverse events, apart from occasional temporary and minor dizziness. There was no significant difference in total MDS-UPDRS-III scores between groups, presumably due to the placebo effect. Additional analyses demonstrated that facial and lower-limb sub-scores significantly improved with active treatment, while gait and lower-limb sub-scores significantly improved with sham treatment. Approximately 70% of participants responded to active treatment (≥5 decrease in MDS-UPDRS-III score) and improved in all sub-scores, while sham responders improved in lower-limb sub-scores only. tPBM appears to be a safe treatment and improved several PD motor symptoms in patients that responded to treatment. tPBM is proving to be increasingly attractive as a possible non-pharmaceutical adjunct therapy.

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white paper

PBM successfully treating Covid-related Brain Fog

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Robert Bowen and Praveen R. Arany
Shepherd University, West Virginia University, and University at Buffalo
March 28, 2023

Abstract:
There is increasing recognition of post-COVID-19 sequelae involving chronic fatigue and brain fog for which Photobiomodulation (PBM) therapy has been utilized. This open-label, pilot, human clinical study examined the efficacy of two PBM devices – e.g., a helmet (1070 nm) for transcranial (tPBM); and a light bed (660 and 850 nm) for whole body (wbPBM) over a four-week period, with 12 treatments for two separate groups (n = 7 per group). Subjects were evaluated with a neuropsychological test battery including Montreal Cognitive Assessment (MoCA), digit symbol substitution test (DSST), trail-making tests A and B, physical reaction time (PRT); and a quantitative electroencephalography system (WAVi), Pre- and Post- the treatment series. Each device for PBM delivery was associated with significant improvements in cognitive tests (p < 0.05 and beyond). Changes in WAVi supported the findings. This study outlines the benefits of utilizing PBM therapy (transcranial or whole-body) to help treat long COVID brain fog.

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white paper

Emerging evidence is increasingly supporting the use of transcranial photobiomodulation (tPBM) to improve symptoms of neurodegenerative diseases, including Parkinson’s disease (PD)

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ABSTRACT: The main objective of this literature review was to analyze the efficacy of (PBM) therapy application on subjects with chronic pain and inflammation, and furthermore, to evaluate the methodological quality of the collected literature. The search was conducted using five databases: PubMed, ProQuest, Scopus, Web of Science, and PEDro. The keywords “low level laser therapy”, “chronic pain”, and “inflammation” provided the selection of RCTs that were published within the last 5 years, conducted in humans, and written in English. The PEDro Internal Validity Scale (IVS) checklist was used to evaluate the risk of bias in the included studies. A total of 11 articles were selected, all of them RCTs. Of the articles, five showed that PBM positively influences chronic pain, while another showed the same but only in the short term. In two other articles, the patient’s inflammation improved markedly. In one article there was no improvement in chronic pain and in another, there was no improvement in inflammation. Four articles demonstrated that PBM is beneficial in acute pain. Furthermore, six studies were given an “excellent” score and the remaining five a “good” score based on the IVS. Photobiomodulation has beneficial effects on chronic pain and inflammation, although more research needs to be completed in this line for this to be clarified as the existence of RCTs on this subject is limited.

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white paper

Transcranial Photobiomodulation Treatment: Significant Improvements in Four Ex-Football Players with Possible Chronic Traumatic Encephalopathy

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January 31, 2023

Abstract:
Chronic traumatic encephalopathy, diagnosed postmortem (hyperphosphorylated tau), is preceded by traumatic encephalopathy syndrome with worsening cognition and behavior/mood disturbances, over years. Transcranial photobiomod- ulation (tPBM) may promote improvements by increasing ATP in compromised/stressed cells and increasing local blood, lymphatic vessel vasodilation.

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1 BSW study Aging Disease

Transcranial Near Infrared Light Stimulations Improve Cognition in Patients with Dementia

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Abstract

Dementia is a complex syndrome with various presentations depending on the underlying pathologies. Low emission of transcranial near-infrared (tNIR) light can reach human brain parenchyma and be beneficial to a number of neurological and neurodegenerative disorders. We hereby examined the safety and potential therapeutic benefits of tNIR light stimulations in the treatment of dementia. Patients of mild to moderate dementia were randomized into active and sham treatment groups at 2:1 ratio. Active treatment consisted of low power tNIR light stimulations with an active photobiomodulation for 6 min twice daily during 8 consequent weeks. Sham treatment consisted of same treatment routine with a sham device. Neuropsychological battery was obtained before and after treatment. Analysis of variance (ANOVA) was used to analyze outcomes. Sixty subjects were enrolled. Fifty-seven subjects completed the study and had not reported health or adverse side effects during or after the treatment. Three subjects dropped out from trial for health issues unrelated to use of tNIR light treatment. Treatment with active device resulted in improvements of cognitive functions and changes were: an average increase of MMSE by 4.8 points; Logical Memory Tests I and II by ~3.0 points; Trail Making Tests A and B by ~24%; Boston Naming Test by ~9%; improvement of both Auditory Verbal Learning Tests in all subtest categories and overall time of performance. Many patients reported improved sleep after ~7 days of treatment. Caregivers noted that patients had less anxiety, improved mood, energy, and positive daily routine after ~14-21 days of treatment. The tNIR light treatments demonstrated safety and positive cognitive improvements in patients with dementia. Developed treatment protocol can be conveniently used at home. This study suggests that additional dementia treatment trials are warranted with a focus on mitigating caregivers’ burden with tNIR light treatment of dementia patients.

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1NIR Helmet

Photobiomodulation with Near Infrared Light Helmet in a Pilot, Placebo Controlled Clinical Trial in Dementia Patients Testing Memory and Cognition

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Abstract

Alzheimer’s disease (AD) is a common, chronic expensive debilitating neurodegenerative disease with no current treatments to prevent the physical deterioration of the brain and the consequent cognitive deficits. The current pathophysiology of Alzheimer’s disease is the accumulation of neurofibrillary tangles (NFTs) of hyperphosphorylated tau protein and amyloid-beta (Aβ) plaques. Antibody therapy of Tau and Amyloid beta, vaccines and other methods to decrease Tau and or Amyloid have not been successful after considerable pharmaceutical and biotech efforts. For example, Eli Lilly announced a major change to its closely watched clinical trial for the Alzheimer’s drug solanezumab which failed to reach statistical significance. Recently, a report on animal models using photomodulation with near infrared light to treat AD pathology in K369I tau transgenic model (K3) l engineered to develop neurofibrillary tangles, and the
APPs/PSEN1dE9 transgenic model (APP/PS1) to develop amyloid plaques. Mice were treated with NIR 20 times over a four-week period and NIR treatment (600-1000 nm) was associated with a reduction in the size and number of amyloid-β plaques in the neocortex and hippocampus. We now report a small pilot double blind, placebo-controlled trial (n=11) 6 active, 3 controls and 2 dropouts assessing the effect of 28 consecutive, six minute transcranial sessions of near infrared (NIR) stimulation using 1060-1080 nm light emitting diodes.

Subjects were independently diagnosed with dementia conducted in an outpatient behavioral healthcare clinic. IRB approval was obtained through the Quietmind Foundation’s institutional review Board (IRB). Results showed changes in executive functioning; clock drawing, immediate recall, praxis memory, visual attention and task switching (Trails A&B) as well as a trend of improved EEG amplitude and connectivity measures. Neuroplasticity has also been reported with NIR light stimulation and mitochondrial enhancement.

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diagram

Improvements in clinical signs of Parkinson’s disease using photobiomodulation: a prospective proof of concept study

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Abstract

Background: Parkinson’s disease (PD) is a progressive neurodegenerative disease with no cure and few treatment
options. Its incidence is increasing due to aging populations, longer disease duration and potentially as a COVID-19
sequela. Photobiomodulation (PBM) has been successfully used in animal models to reduce the signs of PD and to
protect dopaminergic neurons.
Objective: To assess the effectiveness of PBM to mitigate clinical signs of PD in a prospective proof-of-concept
study, using a combination of transcranial and remote treatment, in order to inform on best practice for a larger
randomized placebo-controlled trial (RCT).
Methods: Twelve participants with idiopathic PD were recruited. Six were randomly chosen to begin 12 weeks of
transcranial, intranasal, neck and abdominal PBM. The remaining 6 were waitlisted for 14 weeks before commencing
the same treatment. After the 12-week treatment period, all participants were supplied with PBM devices to
continue home treatment. Participants were assessed for mobility, fine motor skills, balance and cognition before
treatment began, after 4 weeks of treatment, after 12 weeks of treatment and the end of the home treatment
period. A Wilcoxon Signed Ranks test was used to assess treatment effectiveness at a significance level of 5%.
Results: Measures of mobility, cognition, dynamic balance and fine motor skill were significantly improved (p <
0.05) with PBM treatment for 12 weeks and up to one year. Many individual improvements were above the minimal
clinically important difference, the threshold judged to be meaningful for participants. Individual improvements
varied but many continued for up to one year with sustained home treatment. There was a demonstrable
Hawthorne Effect that was below the treatment effect. No side effects of the treatment were observed.

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diagram of human body undergoing clinical trial

Remote Photobiomodulation Treatment for the Clinical Signs of Parkinson’s Disease: A Case Series Conducted During COVID-19

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Abstract

Objective: To assess whether remote application of photobiomodulation (PBM) is effective in reducing clinical
signs of Parkinson’s disease (PD).
Background: PD is a progressive neurodegenerative disease for which there is no cure and few treatment
options. There is a strong link between the microbiome–gut–brain axis and PD. PBM in animal models can
reduce the signs of PD and protect the neurons from damage when applied directly to the head or to remote
parts of the body. In a clinical study, PBM has been shown to improve clinical signs of PD for up to 1 year.
Methods: Seven participants were treated with PBM to the abdomen and neck three times per week for 12
weeks. Participants were assessed for mobility, balance, cognition, fine motor skill, and sense of smell on
enrolment, after 12 weeks of treatment in a clinic and after 33 weeks of home treatment.
Results: A number of clinical signs of PD were shown to be improved by remote PBM treatment, including
mobility, cognition, dynamic balance, spiral test, and sense of smell. Improvements were individual to the
participant. Some improvements were lost for certain participants during at-home treatment, which coincided
with a number of enforced coronavirus disease 2019 (COVID-19) pandemic lockdown periods.
Conclusions: Remote application of PBM was shown to be an effective treatment for a number of clinical signs
of PD, with some being maintained for 45 weeks, despite lockdown restrictions. Improvements in clinical signs
were similar to those seen with the application of remote plus transcranial PBM treatment in a previous study.
Clinical Trial Registration number: U1111-1205-2035.

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