Study of Biophoton Therapy for Brain Disorders

This study is testing a device called a Biophotonizer for people with brain disorders like Alzheimer's disease, dementia, Parkinson's disease, and traumatic brain injury. The Biophotonizer creates a strong biophoton field, which researchers believe helps the body heal itself. You might be able to join if you are at least 18 years old, have a diagnosed brain disorder, and have a caregiver who can support your involvement. The study will look at how the Biophotonizer impacts your overall quality of life and your thinking abilities (cognitive capacity) over 2 to 4 weeks. This study is trying to confirm earlier findings that suggested this therapy was safe and helpful.

Study design
This is a randomized, triple-blinded, placebo-controlled study involving about 80 participants. This means participants are randomly assigned to receive either the Biophotonizer or a placebo device, and neither you, your caregiver, nor the study staff will know which you are receiving at first.
What's involved
You will live in a hotel-like research center for 4 to 6 weeks. You will use a study device for at least 8 hours every night during sleep for the first 2 weeks, and potentially longer.
Compensation
Not stated in the trial record.
Follow-up
Your overall life quality and cognitive capacity will be measured at 0-2 weeks and 0-4 weeks after starting the study treatment.

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NCT06147999

Impact of a Biophoton Therapy on Patients With Brain Disorders

Recruiting
NAAges 18+InterventionalTreatment
First Institute of All Medicines
~80 participants
Updated 2025-08-08 on ClinicalTrials.gov
What's tested:Biophotonizer - a Biophoton Generator

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Life Quality impacted by Biophoton Therapy
Measured over 0-2 weeks, 0-4 weeks after starting the study treatment.
+1 more outcome measured
Brain Disorders - Alzheimer's Disease, Dementia, Parkinson's Disease, Traumatic Brain Injury
1 sites across 1 states
Pennsylvania1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Must meet conditions for approval.
Must be 18-years or older and stay in a hotel.
Must have a caregiver willing to support the participant's full involvement in the study. • The caregiver can assist in completing all study surveys.
Can provide informed consent or can be assisted by caregiver.
Can provide a clinical diagnosis of a brain disorder.
Can complete all study procedures during the study.
Must be fluent in English (or the Caregiver can fully translate).
Women of childbearing age must provide results of a pregnancy test in order to participate.

Exclusion

Any untreated mental illnesses, that would affect study participation. This will be judged by the caregiver, or by the clinical study medical expert.
Someone that relies on a ventilator.
Someone who has a deep brain stimulator, pacemaker, or any implanted electronic devices.
Co-morbid conditions that would interfere with study activities or response to treatment, which may include severe chronic pulmonary disease, history of uncontrolled seizures, acute or chronic infectious illness, severe diabetes, kidney failure, or any end-of-life prognosis.
Is participating in another investigational drug or device trial.
Has an active infectious disease, such as COVID-19.
Pregnant women.
  • Overall Life Quality impacted by Biophoton Therapy0-2 weeks, 0-4 weeks after starting the study treatment.

    Short Form Health Survey (SF-36) will be used to assess life quality: scored from 0 (worst health) to 100 (best heath).

  • Cognitive Capacity impacted by Biophoton Therapy0-2 weeks, 0-4 weeks after starting the study treatment.

    Montreal Cognitive Assessment (MOCA), Score below 10, severe cognition damage; 26-30, normal cognition.