Brain Disorders - Alzheimer's Disease, Dementia, Parkinson's Disease, Traumatic Brain InjuryAlzheimerNCT06147999
Impact of a Biophoton Therapy on Patients With Brain Disorders
A study testing Biophotonizer - a Biophoton Generator in people with Brain Disorders - Alzheimer's Disease, Dementia, Parkinson's Disease, Traumatic Brain Injury, run by First Institute of All Medicines at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Disorders - Alzheimer's Disease, Dementia, Parkinson's Disease, Traumatic Brain Injury
- What is being tested?
- Biophotonizer - a Biophoton Generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2023to 8 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tesla MedBed Center, 139 Pittsburgh Road, Butler, PA 16001
Butler, Pennsylvania, 16001
Jessica Jackson, PhD Candidate, 3029222486, jessica.jackson@firstallmed.org
Audrey Ager, 7248101020, Audrey.ager@teslabiohealing.com
About this study
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.
Read the 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.
- Conditions
- Brain Disorders - Alzheimer's Disease, Dementia, Parkinson's Disease, Traumatic Brain Injury
- Being tested
- Biophotonizer - a Biophoton Generator
- Keywords
- Alzheimer's Disease, and/or, dementia, and/or, Parkinson's Disease, and/or, Traumatic Brain Injury, and/or
- Medical subject headings
- Dementia, Parkinson Disease, Brain Injuries, Traumatic, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biophotonizer - a Biophoton GeneratorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Biophotonizer - a Biophoton Generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 0-2 weeks, 0-4 weeks after starting the study treatment.
Secondary outcomes (4)
Neurological Examination impacted by Biophoton Therapy
Neurological Examination by a Study Physician. The higher the score, the healthier the participant.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0-2 weeks, 0-4 weeks after starting the study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start8 Nov 2023
- Primary completion8 Nov 2026 (estimated)
- Study completion8 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Disorders - Alzheimer's Disease, Dementia, Parkinson's Disease, Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Institute of All Medicines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147999
- Sponsor's protocol ID
- FIAM-BD369
- Acronym
- Alzheimer
- Status last verified
- Aug 2025
- First submitted
- 14 Nov 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study Protocol: Impact of a Biophoton Therapy on Patients with Brain Disorders
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Biophoton Therapy on Patients With Brain Disorders
- ClinicalTrials.gov ID
- NCT06147999
- Acronym / sponsor ID
- Alzheimer / FIAM-BD369
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Institute of All MedicinesUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 8 Nov 2026 (estimated)
- Study completion
- 8 Nov 2026 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Biophotonizer - a Biophoton GeneratorThe 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 |
| Control Group | Placebo comparator | Device: Biophotonizer - a Biophoton GeneratorThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biophotonizer - a Biophoton GeneratorA 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. | Device | Control Group, Treatment Group |
Primary outcome
Overall Life Quality impacted by Biophoton Therapy
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Short Form Health Survey (SF-36) will be used to assess life quality: scored from 0 (worst health) to 100 (best heath).
Cognitive Capacity impacted by Biophoton Therapy
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Montreal Cognitive Assessment (MOCA), Score below 10, severe cognition damage; 26-30, normal cognition.
4 secondary outcomes
Neurological Examination impacted by Biophoton Therapy
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Brain function change impacted by Biophoton Therapy
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Brain Bio-Energy impacted by Biophoton Therapy
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Blood Circulation impacted by Biophoton Therapy
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No. Study Protocol: Impact of a Biophoton Therapy on Patients with Brain Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tesla MedBed Center, 139 Pittsburgh Road, Butler, PA 16001
Butler, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biophotonizer - a Biophoton Generator in people with Brain Disorders - Alzheimer's Disease, Dementia, Parkinson's Disease, Traumatic Brain Injury, run by First Institute of All Medicines at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Life Quality impacted by Biophoton Therapy (time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.