Clinical Research Study

Learn about a clinical trial evaluating a new transcranial photobiomodulation (tPBM) device in individuals with Mild Cognitive Impairment (MCI) and early-stage dementia due to Alzheimer’s Disease.



Neuronic Research Line Number:


+1 (407) 801-4238

About our Clinical Trial

In this clinical trial, we will be evaluating various transcranial photobiomodulation (tPBM) protocols utilizing the Neuradiant device as an intervention for mild Cognitive Impairment and early-stage dementia due to Alzheimer’s disease.

About our Clinical Trial

We will compare the effects of PBM at two different wavelengths, specifically 1040 nm and 1070 nm. This comparison will be conducted using the Neuradiant device.
This category will not include a sham control group.

All biological activity in our body requires ATP just like plants require chlorophyl.

Transcranial photobiomodulation is painless, non-invasive, systemic, drug-free and has shown to have no negative side effects when used appropriately.

A Study from Home

The clinical trial lasts 16 to 18 weeks. The Neuradiant helmet will be sent to your home with setup and usage instructions. You'll be responsible for conducting this study independently at home. You can either follow the given guidelines by yourself or seek help from a family member or caregiver.

A Study from Home
Fully Remote

Fully Remote

The research team will track your progress via biweekly online meetings on the Healthie portal, totaling six sessions. During these online meetings, your progress will be assessed, and you'll complete 3 online tests at the beginning, middle, and end of the study.

Lighting the path for answers.

You will be randomly assigned to a specific protocol or possibly a control group with a non-functional device. Neither you nor the researchers will know if you have a real or sham device to prevent bias.

Tracking Progress

You'll also need to undergo 2 electroencephalogram (EEG) tests: one before starting with the device and another post-intervention, after the 16th week. We'll match you with a nearby testing location, no more than 20 miles away. An EEG is a non-invasive test that captures the brain's electrical activity using sensors placed on the scalp.

Timeline

Timeline
Upon full participation, Neuronic will thank you with a $75 gift card.

How to determine your eligibility

The research team will review further eligibility criteria with you or your caregiver/family member.

Your safety is our highest priority. Should you have queries or apprehensions at any stage of the clinical trial, a member of our study team will be available to assist.

Choosing to participate in the Neuronic Study is entirely up to you. If you decide to participate in this research study, you are always free to withdraw at any time, for any reason, without any penalty or effect on your care.

Talk to your doctor if you have any questions about your health conditions and recommendations to participate in this clinical trial.

The information you provide will be kept confidential*

* If you qualify and give your permission, your answers will be submitted to the study team, who will contact you to discuss your possible participation. The information you provide will be used only in association with your possible participation in this clinical research study.

Participation Requirements

You may be eligible to participate if you:

  • Are 50-80 years of age.
  • Located in the United States.
  • Have been diagnosed with mild cognitive impairment (MCI) or early dementia due to Alzheimer’s disease by a neurologist.
  • Have a computer AND smartphone with internet connection.
  • Have a caregiver (or spouse/family member) willing to help the participant to follow the study protocol.
  • Able and willing to drive for up to 20 miles to obtain 2 EEG tests (one test at the beginning and end of the study).
See Eligibility Form

FAQs

What about my current medications?

Continue taking your medications as prescribed. However, always communicate with your physician throughout the study period.

What is an EEG test?

An electroencephalogram (EEG) test is a simple and painless procedure used to measure the electrical activity in your brain. During the test, small sensors are attached to your scalp using a special gel or adhesive. These sensors pick up the brain's electrical signals and display them on a computer. You'll typically sit during the procedure, and you might be asked to do certain tasks or relax. It's a safe way to understand how your brain is working.

How long is the study duration?

The study lasts between 16 to 18 weeks. We will deliver the Neuradiant 1070 device to your home and provide instructions for use. The study can conveniently be done at home with periodic online check-ins. You will only be required to physically attend to a nearby clinic twice to obtain an electroencephalogram (EEG) test.

Why is this clinical research being conducted?

This clinical research is being conducted for two distinct purposes. In Part 1 of the study, we aim to compare the effects of PBM at two different wavelengths, specifically 1040 nm and 1070 nm, utilizing the Neuradiant device, enabling us to assess the efficacy of the active PBM intervention.

What are the risks in participating in this clinical research study?

You could experience side effects associated with the active tPBM device or the placebo. Your symptoms may not improve or may get worse during the clinical research study. The study team will discuss all the possible risks in detail with you.

What is Mild Cognitive Impairment (MCI) and Mild Dementia due to Alzheimer’s disease?

In the early stages of Alzheimer's disease, it's common for individuals to experience mild cognitive impairment (MCI) or mild dementia. During this phase, while there may be memory lapses or other cognitive challenges, most individuals can still manage most daily tasks independently. ¹Often, the individual might feel they're becoming forgetful, and their family or close friends might observe behavioral changes. ²

A doctor can pinpoint these symptoms using various diagnostic tools and questionnaires. Some typical difficulties faced during mild cognitive impairment and mild dementia include²: Struggling to recall the right word or name.Forgetting recent readingsNot remembering names of new acquaintancesEncountering challenges while handling specific tasks at work or in social situationsMisplacing or losing valuable itemsFacing increased troubles in organizing and planning.

References:

1. Mild cognitive impairment. Alzheimer’s Association. Accessed August 16, 2023. https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment

2. Stages of Alzheimer’s/Alzheimer’s and dementia. Alzheimer’s Association. Accessed August 16, 2023. https://www.alz.org/alzheimers-dementia/stages

3. How is Alzheimer's disease diagnosed? U.S. Department of Health and Human Services. National Institute on Aging. https://www.nia.nih.gov/health/how-alzheimers-disease-diagnosed

Will I have to pay for anything if I choose to participate?

All study-related procedures and the Neuradiant 1070 device will be provided at no cost.

What happens if I face any side effects or discomfort?

Some participants might experience signs of overstimulation like dizziness, headaches, or fatigue. These symptoms are generally mild and resolve within hours. It's important to stay hydrated and have eaten prior to using the device.

How is my personal data protected?

Your privacy is paramount. All personal and medical data is kept confidential and will be anonymized. The data will only be accessible to authorized personnel, as outlined in the informed consent process.

Who is sponsoring the study?

Neuronic Devices Operations GmbH is sponsoring the study.

What if I decide to withdraw from the study?

Your participation is entirely voluntary, and you can withdraw at any time. If you choose to leave the study before its completion, the device must be returned to Neuronic within 2 weeks.

Will I be compensated for my participation?

Yes! As a token of our gratitude, you will receive a $75 gift card from Neuronic upon successful completion of the study.

Do you have questions?

For any questions or concerns, feel free to contact us.

Contact Research Team