Impact of a Biophoton Therapy on Patients With Brain Disorders

NCT06147999 | Recruiting FDA Device

• 1 other identifier: FIAM-BD369
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Alzheimer's Disease, and/or; dementia, and/or; Parkinson's Disease, and/or; Traumatic Brain Injury, and/or

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Neurological Examination impacted by Biophoton Therapy

  0-2 weeks, 0-4 weeks after starting the study treatment.

• Brain function change impacted by Biophoton Therapy

  0-2 weeks, 0-4 weeks after starting the study treatment.

• Brain Bio-Energy impacted by Biophoton Therapy

  0-2 weeks, 0-4 weeks after starting the study treatment.

• Blood Circulation impacted by Biophoton Therapy

  0-2 weeks, 0-4 weeks after starting the study treatment.

Other Outcomes (1)

• Safety of the Study participant impacted by Biophoton Therapy

  0-2 weeks, 0-4 weeks after starting the study treatment.

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

Biophotonizer - a Biophoton Generator DEVICE

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.

Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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.

Sponsors & Collaborators

• First Institute of All Medicines: lead

Study Sites (1)

Tesla MedBed Center, 139 Pittsburgh Road, Butler, PA 16001

Butler, Pennsylvania, 16001, United States

RECRUITING

MeSH Terms

Conditions

Dementia; Parkinson Disease; Brain Injuries, Traumatic; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Tauopathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The 14 inactive Biophoton Generators packed with the same 32-Oz metal can as the active Treatment device will be labeled with a code and placed under a hotel bed for use. The shape, weight and overall looking is identical between the active and placebo devices.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 28, 2023
• Study Start: November 8, 2023
• Primary Completion (Estimated): November 8, 2026
• Study Completion (Estimated): November 8, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)