Impact of a Biophoton Therapy on Patients With Brain Disorders (Alzheimer)

First Institute of All Medicines

Status: Enrolling

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

Treatments: Device: Biophotonizer - a Biophoton Generator

Study type: Interventional

Funder types: Other

Identifiers

NCT06147999

FIAM-BD369

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

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

Treatment:

Device: Biophotonizer - a Biophoton Generator

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Device: Biophotonizer - a Biophoton Generator