Transcranial Photobiomodulation for Cognitive Decline
Recruiting in Palo Alto (17 mi)
Overseen byRobert M Brothers, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas at Arlington
Disqualifiers: Brain injuries, Epilepsy, Pacemakers, others
Trial Summary
What is the purpose of this trial?The overall research objective of this proposal is to determine the acute and chronic impact of transcranial photobiomodulation on indices of cerebral vascular health and neurocognitive function.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
What data supports the effectiveness of the treatment Transcranial Photobiomodulation for Cognitive Decline?
Research shows that transcranial photobiomodulation (using red or near-infrared light) can improve memory, motor function, and processing speed in healthy middle-aged individuals. It has also shown promising results in treating brain disorders like traumatic brain injury, stroke, and Alzheimer's disease, suggesting potential benefits for cognitive decline.
12345Is transcranial photobiomodulation generally safe for humans?
Research on transcranial photobiomodulation (PBM), also known as low-level light therapy, shows it is generally safe for humans. Studies, including those on healthy individuals and various brain disorders, report no adverse effects, suggesting it is a promising and safe approach for brain health.
12345How does the treatment Transcranial Photobiomodulation differ from other treatments for cognitive decline?
Transcranial Photobiomodulation is unique because it uses red or near-infrared light to stimulate and protect brain cells, potentially improving memory and cognitive function. Unlike traditional treatments, it involves wearing a helmet that emits light, which is non-invasive and has shown promise in enhancing brain function without adverse effects.
12346Eligibility Criteria
This trial is for individuals with vascular disease, cognitive decline, or Alzheimer's. It includes those with peripheral arterial or vascular disease who are interested in a non-invasive treatment aimed at improving brain health and cognition.Inclusion Criteria
I am between 18 and 80 years old.
Exclusion Criteria
I have not donated more than 550 ml of blood in the last 8 weeks.
Abnormal results from the blood screening will not impact eligibility for the study.
Individuals with brain injuries/surgeries in a year before the study and individuals who cannot provide consent on their own will be excluded from participation.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive transcranial photobiomodulation (tPBM) therapy up to 8 times over a 4-week period
4 weeks
Up to 8 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the effects of a Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) on brain blood flow and mental function. Some participants will receive no light as a comparison group.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transcranial PhotobiomodulationExperimental Treatment1 Intervention
Transcranial Photobiomodulation (tPBM) is a novel and non-invasive strategy that utilizes a helmet that delivers low-level laser therapy to activate intracellular enzymatic pathways leading to an increase in mitochondrial activity, cerebral oxygenation, and thus neural and overall brain function. Importantly, this approach improves cognitive function in various animal models and limited human populations. Furthermore, there is limited evidence to suggest that these neurocognitive improvements are in-part related to increases in cerebral blood flow and cerebral vascular function/health.
Group II: Sham conditionPlacebo Group1 Intervention
In this condition the participants will wear the Transcranial Photobiomodulation (tPBM) headgear; however, no light will be delivered.
Transcranial Photobiomodulation is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Transcranial Photobiomodulation for:
- Not approved for any indication; under investigation for Alzheimer's Disease and Mild Cognitive Impairment
🇪🇺 Approved in European Union as Transcranial Photobiomodulation for:
- Not approved for any indication; under investigation for Alzheimer's Disease and Mild Cognitive Impairment
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UT Arlington - Science and Engineering Innovation and Research BuildingArlington, TX
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Who Is Running the Clinical Trial?
The University of Texas at ArlingtonLead Sponsor
References
Shining light on the head: Photobiomodulation for brain disorders. [2020]Photobiomodulation (PBM) describes the use of red or near-infrared light to stimulate, heal, regenerate, and protect tissue that has either been injured, is degenerating, or else is at risk of dying. One of the organ systems of the human body that is most necessary to life, and whose optimum functioning is most worried about by humankind in general, is the brain. The brain suffers from many different disorders that can be classified into three broad groupings: traumatic events (stroke, traumatic brain injury, and global ischemia), degenerative diseases (dementia, Alzheimer's and Parkinson's), and psychiatric disorders (depression, anxiety, post traumatic stress disorder). There is some evidence that all these seemingly diverse conditions can be beneficially affected by applying light to the head. There is even the possibility that PBM could be used for cognitive enhancement in normal healthy people. In this transcranial PBM (tPBM) application, near-infrared (NIR) light is often applied to the forehead because of the better penetration (no hair, longer wavelength). Some workers have used lasers, but recently the introduction of inexpensive light emitting diode (LED) arrays has allowed the development of light emitting helmets or "brain caps". This review will cover the mechanisms of action of photobiomodulation to the brain, and summarize some of the key pre-clinical studies and clinical trials that have been undertaken for diverse brain disorders.
Photobiomodulation and the brain: a new paradigm. [2020]Transcranial photobiomodulation (PBM) also known as low level laser therapy (tLLLT) relies on the use of red/NIR light to stimulate, preserve and regenerate cells and tissues. The mechanism of action involves photon absorption in the mitochondria (cytochrome c oxidase), and ion channels in cells leading to activation of signaling pathways, up-regulation of transcription factors, and increased expression of protective genes. We have studied PBM for treating traumatic brain injury (TBI) in mice using a NIR laser spot delivered to the head. Mice had improved memory and learning, increased neuroprogenitor cells in the dentate gyrus and subventricular zone, increased BDNF and more synaptogenesis in the cortex. These highly beneficial effects on the brain suggest that the applications of tLLLT are much broader than at first conceived. Other groups have studied stroke (animal models and clinical trials), Alzheimer's disease, Parkinson's disease, depression, and cognitive enhancement in healthy subjects.
[Near-infrared laser treatment of acute stroke: from bench to bedside]. [2021]Near-infrared laser therapy (NIRLT) as a transcranial laser therapy (TLT) is currently being investigated as a neuroreparatory and neuroprotective treatment for acute ischemic stroke patients in a pivotal phase III trial (NEST-3). In this review we cover the theoretical background, experimental studies, translational research and the clinical trial program.
Effect of Transcranial Near-Infrared Light 1068 nm Upon Memory Performance in Aging Healthy Individuals: A Pilot Study. [2021]Background: We present a pilot study of near-infrared (NIR) 1068 nm transcranial photobiomodulation therapy (PBM-T). Impact upon motor function, memory, and processing speed in healthy individuals, older than 45 years of age, was evaluated. Methods: PBM-T was performed at home using a transcranial phototherapy device, a helmet that comprised 14 air cooled light emitting diode panel arrays, with a peak wavelength of 1068 nm, full width at half maximum bandwidth of 60 nm and total average optical output power of 3.8 W. The device was used for 6 min twice daily on age-matched middle-aged subjects with normal intellectual function. The US Food and Drug Administration (FDA)-approved computerized assessment tool Automated Neuropsychological Assessment Metrics (ANAM) was adopted to quantify a series of cognitive and motor activities in the participating groups. Results: A significant improvement in motor function, memory performance, and processing speed was observed in healthy individuals with PBM-T compared to the placebo group. No adverse effects were reported. Conclusions: PBM-T may be a promising new approach to improve memory in healthy middle-aged individuals. ClinicalTrials.gov ID: NCT04568057.
Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial. [2023]Photobiomodulation describes the use of red or near-infrared light to stimulate or regenerate tissue. It was discovered that near-infrared wavelengths (800-900 nm) and red (600 nm) light-emitting diodes (LED) are able to penetrate through the scalp and skull and have the potential to improve the subnormal cellular activity of compromised brain tissue. Different experimental and clinical studies were performed to test LED therapy for traumatic brain injury (TBI) with promising results. One of the proposals of this present study is to develop different approaches to maximize the positive effects of this therapy and improve the quality of life of TBI patients.
Photobiomodulation as a promising new tool in the management of psychological disorders: A systematic review. [2021]Photobiomodulation is a brain modulation technique that has become a promising treatment for multiple pathologies. This systematic review collects studies up to 2019 about the beneficial effects of photobiomodulation as a therapy for treating psychological disorders and a tool for modulating cognitive processes. This technique is mostly used for the treatment of depression and stress, as well as to study its effects on psychological variables in healthy subjects. Despite the lack of parameters used, photobiomodulation seems to achieve enough brain penetration to produce beneficial effects in healthy subjects and patients with multiple pathologies. The best parameters are the wavelengths of 810 nm for the treatment of depression and 1064 nm for cognitive enhancement, along with a scalp irradiance of 250 mW/cm2 and a scalp yield of 60 J/cm2. It weekly application on the bilateral prefrontal area and the default mode network seems to be ideal for the maintenance of the effects. Photobiomodulation could be used as an effective and safe therapy for the treatment of multiple psychological pathologies.