Clinical trials of light therapy to reduce symptoms of Alzheimer's
This article gives a brief overview of the ongoing clinical trials for Alzheimer’s and discusses earlier clinical trials.
“Published research shows the more intense 40 Hz pulse rate, which correlates with gamma (γ) oscillations within the brain is associated with higher cognitive processing capability and memory consolidation.” Vielight.
Ongoing clinical trial: could photobiomodulation improve cognitive functioning and quality of life in Alzheimer’s patients?
Vielight Neuro Gamma 3
There is a current clinical trial to study “the effects of Vielight Neuro RX Gamma device on patients with Alzheimer’s disease. More specifically, the trial is designed to find out whether transcranial-intranasal photobiomodulation could improve cognitive functioning and quality of life in patients with moderate to severe Alzheimer’s Disease.”
The study participants used the Neuro RX Gamma device for home-based treatment. The Neuro RX Gamma uses low-energy LEDs to deliver near-infrared light energy at a wavelength of 810-nm, pulsed at 40 Hz.
The Neuro RX Gamma is a medical grade version of the Neuro Gamma, which means it is produced in a facility that complies with medical manufacturing laws. The Neuro RX Gamma and the Neuro Gamma 3 (available for purchase by consumers) have the same output - the same type of light, pulse, and intensity.
The study involves 228 study participants in a double-blind, randomized trial, including a placebo control group. Eight trial sites in North America were involved in the study. The study started in June 2019 and a completion date is not yet set, due to recruitment issues during the pandemic. (ClinicalTrials.gov and Vielight.com/research).
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Ongoing clinical trial: what is the impact of photobiomodulation on biomarkers of Alzheimer’s disease?
The University of California, San Francisco, has an ongoing clinical trial Impact of Photobiomodulation on Biomarkers of Alzheimer’s Disease. The study was completed in January 2021, and the results have not been published yet.
The pilot program involved 16 participants, with patients randomly assigned to a group that used the Vielight Neuro Gamma for 16 weeks, once every other day (e.g., Monday, Wednesday, Friday) for 20 minutes. A second group used a sham (fake) Vielight device. The participants were then be assessed for the impacts of Photobiomodulation on cognition, behavior, and biomarkers of Alzheimer’s disease.
Completed Clinical Trials
2018 pilot clinical trial using the Vielight Neuro Gamma with dementia patients
Vielight Neuro Gamma 3
Results of the study Photobiomodualtion for Improving Brain Function in Dementia were presented at the Alzheimer’s Association International Conference in July 2018. The study was done by the University of California, San Francisco & San Francisco VA Medical Center. You can view the Data Presentation and read the details of the Clinical Trial. Publication of the study is upcoming.
Positive Findings
Eight older adults diagnosed with dementia participated in the study. Half were assigned 12 weeks of Photobiomodulation (PBM) using the Vielight Neuro Gamma (pulse frequency of 40 Hertz) every other day for 12 weeks. The other half were assigned Usual Care. Assessments for behavior and cognitive function, and neuroimaging were done periodically throughout the study.
Results at the end of the 12-week study:
Cognitive and behavioral assessment scores improved in the Photobiomodulation group but declined in the Usual Care group.
There was greater cerebral blood flow (CBF) in the Photobiomodulation group compared to the Usual Care group.
The Photobiomodulation group showed greater connectivity in the Default Mode Network (DMN), an integrated group of brain structures that becomes dysregulated in Alzheimer’s Disease. Note: the Vielight Neuro Gamma was designed to target the nodes of the default mode network.
The Usual Care group showed decreased connectivity in the Default Mode Network.
Study conclusions:
“These behavioral results reaffirm Saltmarche et al. findings that transcranial and intranasal PBM benefits cognitive function in patients with dementia.”
The preliminary findings of increased cerebral blood flow and Default Mode Network connectivity support the potential of photobiomodulation as a safe, non-pharmacological intervention that can be used to treat patients with dementia in their homes.”
This graph is from the poster about this research study which you can view here.
Vielight offers an 80% refund policy, valid within six months from the time of purchase.
2017 Study shows Significant Improvement in Cognition in dementia patients after photobiomoduLation treatment using Vielight neuro.
Results of Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation: Case Series Report, (Saltmarche et al.) was published online on August 1, 2017. The authors of the study are preeminent researchers in the field of Photobiomodulation. Five patients with mild to moderately severe cognitive impairment were given 12 weeks of photobiomodulation and then a follow-up 4-week period of no treatment. Patients were assessed with the Mini-Mental State Exam and Alzheimer's Disease Assessment Scale (ADAS-cog) tests.
The patients were given these treatments:
In-clinic use of the Vielight Neuro, 2x per week for 2 weeks, then 1x per week for the next 10 weeks.
The Vielight Neuro (an older device) had a pulse rate of 10 Hz, the same as the updated Vielight Neuro Alpha, but it had 1/3rd of the power of the Vielight Neuro Alpha.
Daily in-home use of the Vielight 810, an intranasal device with a pulse frequency of 10 Hz.
The protocol involved weekly, in-clinic use of a transcranial-intranasal PBM device; and daily at-home use of an intranasal-only device.
Results:
Significant improvements in cognition after 12 weeks of the photobiomodulation treatment.
After the 4-week no-treatment period (which followed the 12-week treatment period) all five participants worsened on either one or both of the assessments for cognitive function. This deterioration in cognitive scores is “supportive of the significant improvements present after the 12 weeks of PBM treatments. Deterioration in function and behavior was so marked in one patient (Patient 2) after only 1 week of no treatment that the authors returned the PBM equipment to the family at that time, without further follow-up testing. The family later reported anecdotally that improvements resumed.”
Study conclusions:
"Results showed significant improvement in cognition, functional abilities for daily living, and improved Quality of Life. PBM was very well tolerated, exhibiting no adverse effects. The treatments likely need to be continued, however, on a regular, long-term basis."
This graph is from the published study which you can view here.
Ongoing clinical trials
A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Vielight Neuro RX Gamma Device for the Treatment of Moderate-to-severe Alzheimer's Disease
This feasibility pilot has an estimated completion date of May 2019. The locations for the feasibility pilot are Chatham Kent Clinical Trials Research Centre (Chatham, Ontario, Canada) and The Centre for Memory and Aging (Toronto, Ontario, Canada). The sponsor of the feasibility pilot is Vielight, Inc.
One of the things that the study is designed to do is compare the effects of near infra-red light which is delivered with synchronized pulse rates across all the diodes, in contrast to devices that provide asynchronized (not synchronized) pulses between the different diodes.
The light output of the Neuro RX Gamma and the Neuro Gamma is the same, 810-nm near-infrared light energy, pulsed at 40 Hz. The RX Gamma is manufactured to meet medical device standards, unlike the Neuro Gamma, which is classified as a Wellness Device and does not require a doctor’s prescription.
The RX Gamma is produced in a medical manufacturing setting which is ultra-sterile, and a few of the component parts of the headset are a different type of material (possibly for durability).
The study is using variations of Vielight Neuro RX Gamma (see sidebar) which emits near-infrared light at the 810-nm wavelength, with a pulse rate of 40 Hz. The study had an estimated sixty participants who were each given a twenty-minute treatment, six days per week, for 12 weeks.
The sixty participants were randomly assigned to one of three study groups:
Treatment with the Neuro RX Gamma device which provides near infra-red light through four diodes positioned over the scalp and one placed inside the nostril. The synchronous device provides a synchronized pulse frequency of 40 Hz from all LED clusters.
Treatment with a Sham Neuro RX Gamma device which has the same appearance and sound as the Neuro RX Gamma device but does not emit the near-infrared light.
Treatment with a Neuro RX Gamma device which provides near infra-red light through four diodes positioned over the scalp and one placed inside the nostril. The asynchronous device alternatively delivers pulses from the intranasal and anterior LEDs vs. from the posterior LEDs.
The study will be looking at multiple outcome measures:
“The EEG recordings will give insight into the effect on the neural activity of the brain of the Neuro RX Gamma synchronized and Neuro RX Gamma asynchronized compared to sham.”
Assessment of changes in cognitive abilities including social interaction, memory, orientation, language, attention, and more.
Assessment of changes in ability to perform activities of daily living.
Assessment of changes in frequency, severity, and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating).
Vielight Neuro RX Gamma Photobiomodulation Device for Moderate to Severe Alzheimer's Disease
A new clinical trial Vielight Neuro RX Gamma Photobiomodulation Device for Moderate to Severe Alzheimer's Disease will soon be enrolling participants. The location of the study is at St. Michael’s Hospital, Toronto, Canada, and is sponsored by Vielight. The estimated start date is January 2019 and estimated completion date of January 2021. The expected enrollment is 228 participants with moderate to severe Alzheimer’s disease.
The device used for the clinical will be the Vielight Neuro RX Gamma, which is a medical grade version of the Vielight Neuro Gamma, available online. (see sidebar, above.)
The study will be assessing multiple outcome measures:
Changes in cognitive abilities including social interaction, memory, orientation, language, attention, and more.
Changes in ability to perform activities of daily living.
Changes in mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Changes in Quality of Life as reported by the patient and the caregiver.
Changes in common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating disorders).