Recruiting

Biophoton Therapy

Sponsor:

First Institute of All Medicines

Code:

NCT06147999

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biophotonizer - a Biophoton Generator

Study Details

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

Study ID

NCT06147999

Start date

Nov 8, 2023

Status verified date

Aug, 2025

Completion date

Nov 8, 2026

Anticipated

Primary completion date

Nov 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

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

placebo comparator: Control Group

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.

Interventions

Biophotonizer - a Biophoton Generator

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.

Primary outcome measure

  • Overall Life Quality impacted by Biophoton Therapy [ Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment. ]
  • Cognitive Capacity impacted by Biophoton Therapy [ Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment. ]

Central Contacts and Locations

Locations

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

Recruiting

Butler, Pennsylvania, United States, 16001

Contacts

Jessica Jackson, PhD Candidate

3029222486jessica.jackson@firstallmed.org

Audrey Ager

7248101020Audrey.ager@teslabiohealing.com

Principal Investigator:

Mariola Smotrys, MD, MS, MBA

More Information

Sponsor

First Institute of All Medicines

Last update posted

Aug 8, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by First Institute of All Medicines on 2025-08-08.