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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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately before the start of the experimental or sham condition intervention. and immediately after the end of the experimental or sham condition intervention. for reporting.

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

0 / 1Eligibility criteria met