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Device
Transcranial Photobiomodulation for Cognitive Decline
N/A
Recruiting
Led By Robert M Brothers, PhD
Research Sponsored by The University of Texas at Arlington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Pregnant subjects, women who are breastfeeding, and children (i.e. younger than 18) will not be recruited for the study. This will be assessed via self-report.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately before the start of the experimental or sham condition intervention. and immediately after the end of the experimental or sham condition intervention.
Summary
This trial aims to study how shining light on the head can affect brain health and cognitive function in the short and long term.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not specified but may include discomfort from wearing the helmet or sensitivity to light for those susceptible to photophobia.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, breastfeeding, or under 18.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately before the start of the experimental or sham condition intervention. and immediately after the end of the experimental or sham condition intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately before the start of the experimental or sham condition intervention. and immediately after the end of the experimental or sham condition intervention.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cerebral vasodilator function
Neurocognitive function
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Photobiomodulation
2021
N/A
~40
Find a Location
Who is running the clinical trial?
The University of Texas at ArlingtonLead Sponsor
45 Previous Clinical Trials
4,808 Total Patients Enrolled
Robert M Brothers, PhDPrincipal InvestigatorUniversity of Texas at Arlington
6 Previous Clinical Trials
239 Total Patients Enrolled