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.See Eligibility Form
Brief Description of the 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.
This study is divided into two distinct categories, with participants randomly assigned to either one.
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.
Will focus on comparing active 1070 nm PBM with a sham control, employing the Neuradiant device. In this category, participants will receive either active PBM treatment or a sham control, allowing us to evaluate the efficacy of the active PBM intervention.
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.
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.
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.
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.
- Are 50-75 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).
Frequently Asked Questions
Here you'll find answers to the most commonly asked questions about the study. If you still have a question, please don't hesitate to get in touch!