Impact of a Biophoton Therapy on Patients With Brain Disorders

Study Overview
=================
Brief Summary
-----------------
Previous clinical studies revealed that the newly developed biophoton therapy has been safe and effective in treating patients with Alzheimer's disease, dementia, stroke, traumatic brain injury, or Parkinson's disease. The current study is to confirm the previous clinical observation by conducting as a randomized, triple-blinded, placebo-controlled prospective intervention clinical research. About 80 patients with brain disorder (Alzheimer's disease, dementia, stroke, traumatic brain injury, Parkinson's disease) will participate in the intervention clinical study at the Tesla MedBed Center located in Butler, PA.

Detailed Description
-----------------
The participant will live in the hotel-like research center for 4 weeks, or 6 weeks if the participants are randomly placed in a placebo group. The initial 2 weeks of participation is triple blinded to record the placebo effects, as each set of the study device is labelled with a unique code for use by only one participant. The change of the placebo device to the treatment device will be performed by the study device management team staff who will not inform the study participant nor study research staff who involve study data collection. Each participant assigned to the Control Group will be treated with 14 placebo devices under the bed plus two placebo devices to place in bed on each side of the head. Each participant assigned to the Treatment Group will receive 14 Biophoton generator devices under the bed plus two Biophoton Generators to place in bed on each side of the head. Each participant will use the Treatment or Control device for at least 8 hours every night for the first 2 weeks during sleep. During the day, participants are welcome to move around the facility, visit people or places. At the end of the first 2 weeks, the study participants will be advised whether she/he will be continually in a treatment group for 2 more weeks or be switched from a placebo group to a treatment group for 4 more weeks. Each participant will be guided by study team staff on their assigned testing day to answer the standard SF-36 questionnaires (SF-36) for measuring life quality, Cognitive Improvement Questionnaires, physician performed neurologic examination, Bio-well energy test, the Electroencephalography (EEG) test, blood flow test, and brain biophoton test, respectively at the baseline, 2 and 4 weeks after the study treatment.

Official Title
-----------------
Impact of a Biophoton Therapy on Patients With Brain Disorders

Conditions
-----------------
Brain Disorders - Alzheimer's Disease, Dementia, Parkinson's Disease, Traumatic Brain Injury

Intervention / Treatment
-----------------
* Device: Biophotonizer - a Biophoton Generator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a randomized, triple-blinded, placebo-controlled prospective intervention clinical research in two groups. About 80 patients with brain disorder will participate in the clinical interventional study at the hotel-like Tesla MedBed Center in Butler, PA, USA.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>The 14 active Biophoton Generators packed with the same 32-Oz metal can will be labeled with a code and placed under a hotel bed. Each participant will rest on the bed during the entire study period for 4 weeks. Participants will receive biophotons inside of the biophoton field generated by 14 active Biophoton Generators | Device: Biophotonizer - a Biophoton Generator<br>* A biophotonizer is a device producing strong biophoton field. These biophotons help the human body to gain self-healing capacity to heal many disorders, including brain disorders.<br>|
| Placebo Comparator: Control Group<br>The 14 inactive Biophoton Generators packed with the same 32-Oz metal can will be labeled with a code and placed under a hotel bed. Each participant will rest on the bed during the entire study period for the first 2 weeks. Then will be switched to the active treatment group for being treated for 4 weeks. Participants will receive placebo effect from the 14 inactive comparators. | Device: Biophotonizer - a Biophoton Generator<br>* A biophotonizer is a device producing strong biophoton field. These biophotons help the human body to gain self-healing capacity to heal many disorders, including brain disorders.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Life Quality impacted by Biophoton Therapy | Short Form Health Survey (SF-36) will be used to assess life quality: scored from 0 (worst health) to 100 (best heath). | 0-2 weeks, 0-4 weeks after starting the study treatment. | 
| Cognitive Capacity impacted by Biophoton Therapy | Montreal Cognitive Assessment (MOCA), Score below 10, severe cognition damage; 26-30, normal cognition. | 0-2 weeks, 0-4 weeks after starting the study treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological Examination impacted by Biophoton Therapy | Neurological Examination by a Study Physician. The higher the score, the healthier the participant. | 0-2 weeks, 0-4 weeks after starting the study treatment. | 
| Brain function change impacted by Biophoton Therapy | Brain function change is to be detected by using an EEG machine. Eye reaction time - the shorter the healthier. | 0-2 weeks, 0-4 weeks after starting the study treatment. | 
| Brain Bio-Energy impacted by Biophoton Therapy | Using Bio-Well GDV Camera device and calculated by multiplication of areas of the brain. The more balanced joules, the better brain energy. | 0-2 weeks, 0-4 weeks after starting the study treatment. | 
| Blood Circulation impacted by Biophoton Therapy | FALCON QUAD measures circulation using the ankle-brachial index. The more balanced measurement, the better blood circulation. | 0-2 weeks, 0-4 weeks after starting the study treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's Disease, and/or, dementia, and/or, Parkinson's Disease, and/or, Traumatic Brain Injury, and/or