NCT06147999 · RECRUITING
Impact of a Biophoton Therapy on Patients With Brain Disorders
This trial is testing a device called a Biophotonizer, which emits biophotons (a form of light energy), to see whether it helps people with brain conditions including Alzheimer's disease, dementia, Parkinson's disease, stroke, or traumatic brain injury. It is Phase NA, meaning it is classified as an interventional study outside the standard phase framework. About 80 participants will be randomized to real or sham (placebo) device sessions at a single center in Butler, Pennsylvania.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-08-08