Chronic StrokeNCT06049849
Can Patients With Chronic Stroke Regain Living Independence by Daily Energizing With Biophoton Generators
A study testing Biophoton Energizing Brain and Whole Body in people with Chronic Stroke, run by First Institute of All Medicines at 1 site in United States.
Trial summary
Study objective The purpose of this clinical research is to verify if the patient with chronic stroke can regain the ability of living independently after daily using Testa BioHealing® Biophoton Generators to increase the energy of the brain and other parts of the body. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Biophoton Energizing Brain and Whole Body
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18-years or older and can live in a hotel
- Must have a caregiver willing to support the participant's full involvement in the study and can assist to complete all study questionnaires
- Can provide informed consent (maybe assisted by Caregiver)
- Has evidence of a clinical diagnosis of stroke occurred at least 6 months ago.
- Has a disability unable to be living independently per Caregiver
- Can complete all study procedures during the study
- Must be fluent in English (or the Caregiver can fully translate)
Who cannot join
- Untreated psychiatric disturbances that would affect trial participation as judged by the Caregiver or by the clinical study medical professional
- Who relies on ventilators
- 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, kidney failure, etc.
- Is participating in another investigational drug or device trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Tesla MedBed Center at Butler-PA
Butler, Pennsylvania, 16001
About this study
Official title: Can Participants With Chronic Stroke Regain Living Independence by Daily Energizing With a Biophoton Generator
Study objective The purpose of this clinical research is to verify if the patient with chronic stroke can regain the ability of living independently after daily using Testa BioHealing® Biophoton Generators to increase the energy of the brain and other parts of the body.
Study design This study is a randomized, triple-blinded, placebo-controlled prospective intervention clinical research. At least 46 patients with chronic stroke will participate in the live-in observational study in a Tesla MedBed Center.
Study patient population The adult patient with a chronic stroke which was defined as a stroke occurred at least 6 months ago with a significant disability unable to have an independent life, is to be considered as a qualified participant.
Read the detailed description
Investigational product and mode of administration The hotel bed is powered by a standardized set of 14 biophoton generators of 32-Oz size, which was previously tested as safe and effective. The active device is FDA registered over-the-counter (OTC) medical device. The device can be used by anyone who wants to increase blood circulation and reduce bodily pains, according to the label claims. For this study, the active or inactive devices will be labeled with individual codes. The participant, caregiver and the study staff cannot know if the hotel room is equipped with a set of active or inactive devices. When the participant is lying on the hotel bed, she/he may or may not receive biophotons. The study physician, participant or the caregiver will record the ADL and other changes, and answer the standard study questionnaires at the baseline, 2, or 4 weeks after study treatment, respectively.
Study procedure Each of all participants assigned to the Control or Treatment Group will be continually treated with the current standard of care (SOC), if any. The Control group will use the coded placebo devices, and the Treatment Group will use the coded treatment product. All coded products will be packed with the same container with the same size and weight. Each participant will use the Treatment or Control device at least for 8-hours every day for 4-weeks during sleep and any daytime during the day. Each participant and caregiver will be guided by the study physician to use Katz Index of Independence in Activities of Daily Living (ADL) to measure the level of life independence. The study physician will perform neurological examination. Stroke Impact Scale (SIS) for stroke-specific health status measurement, SF-36 questionnaires (SF-36) to measure life quality, Electroencephalography (EEG) test, and Bio-Well energy test, will be conducted respectively at the baseline, 2 or 4 weeks after the study treatment. SIS and SF-36 questionnaires will be recalled 4 weeks before the baseline for each participant.
Comparator and mode of administration The same shape, size, and weight of the device without generating biophoton is to be labelled with individual codes and used as a comparator. The comparator device will be placed in the same way as the Treatment device in the hotel room during the designed study period.
Study duration Estimated date of the first participant enrolled: May 2023. The estimated date of the last patient completed: December 2023. The participants randomized in the Control group will be switched to the Treatment after observing the placebo effects for four weeks. They will be treated with the active device for 4-weeks for self-comparison analysis.
Duration of treatment Participants in the Control and Treatment Groups will actively participate in the study for 4-weeks. Each participant and caregiver will answer the standard study questionnaires at the baseline, 2 or 4 weeks of the study, respectively. The participants randomized in the Control will participate in the study for a total of 6 weeks.
- Conditions
- Chronic Stroke
- Being tested
- Biophoton Energizing Brain and Whole Body
- Keywords
- stroke, paralysis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biophoton Energizing Brain and Whole BodyDevice
The patient is to be energized within a strong biophoton field which is constantly generated by active biophoton generators.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Active Biophoton Generators are placed under the hotel bed. Receives: Device: Biophoton Energizing Brain and Whole Body |
| Control Group | Placebo comparator | Placebo-products are placed under the hotel bed. Receives: Device: Biophoton Energizing Brain and Whole Body |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regain Life Independence by Normalizing Activities of Daily Living (ADL).
If the damaged brain is repaired, the participant can perform daily activities.
Measured: 0-2 weeks, 0-4 weeks after starting the study treatment.
Secondary outcomes (4)
Neurologic Examination Using a Standard Neurologic Exam Form to Measure Neurologic Function
The study physician will conduct the standardized neurologic examinations
Measured: 0-2 weeks, 0-4 weeks after starting the study treatment.
Stroke Impact Scale (SIS) to Reflect Paralysis Status Change (fully recovery =300)
Under study physician's guidance, participant will answer the standard questionnaires.
Measured: 0-2 weeks, 0-4 weeks after starting the study treatment.
Brain injury status detected with EEG (electroencephalogram).
Brain injury exists at the baseline and can be repaired with biophotons.
Measured: 0-2 weeks, 0-4 weeks after starting the study treatment.
Life Quality Improvement Measured with a Standard SF-36 Questionnaire
Using Short Form Health Survey (SF-36) to measure life quality.
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 posted22 Sep 2023
- Study start31 Oct 2023
- Primary completion30 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies 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. All patients with chronic stroke will participate in the live-in observational study by sleeping on Tesla MedBed in a special hotel.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
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
- NCT06049849
- Sponsor's protocol ID
- 2022/09/27
- Status last verified
- Feb 2024
- First submitted
- 11 Sep 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: All individual participants' identification information will be kept confidential. All data report forms will have the subject number. The study report and scientific publication will not show any identifiable information of the patient.
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
- Can Participants With Chronic Stroke Regain Living Independence by Daily Energizing With a Biophoton Generator
- ClinicalTrials.gov ID
- NCT06049849
- Acronym / sponsor ID
- 2022/09/27
- Conditions
- Chronic Stroke
- Keywords
- stroke, paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- First Institute of All MedicinesUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Sep 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.
Study objective The purpose of this clinical research is to verify if the patient with chronic stroke can regain the ability of living independently after daily using Testa BioHealing® Biophoton Generators to increase the energy of the brain and other parts of the body.
Study design This study is a randomized, triple-blinded, placebo-controlled prospective intervention clinical research. At least 46 patients with chronic stroke will participate in the live-in observational study in a Tesla MedBed Center.
Study patient population The adult patient with a chronic stroke which was defined as a stroke occurred at least 6 months ago with a significant disability unable to have an independent life, is to be considered as a qualified participant.
Detailed description
Investigational product and mode of administration The hotel bed is powered by a standardized set of 14 biophoton generators of 32-Oz size, which was previously tested as safe and effective. The active device is FDA registered over-the-counter (OTC) medical device. The device can be used by anyone who wants to increase blood circulation and reduce bodily pains, according to the label claims. For this study, the active or inactive devices will be labeled with individual codes. The participant, caregiver and the study staff cannot know if the hotel room is equipped with a set of active or inactive devices. When the participant is lying on the hotel bed, she/he may or may not receive biophotons. The study physician, participant or the caregiver will record the ADL and other changes, and answer the standard study questionnaires at the baseline, 2, or 4 weeks after study treatment, respectively.
Study procedure Each of all participants assigned to the Control or Treatment Group will be continually treated with the current standard of care (SOC), if any. The Control group will use the coded placebo devices, and the Treatment Group will use the coded treatment product. All coded products will be packed with the same container with the same size and weight. Each participant will use the Treatment or Control device at least for 8-hours every day for 4-weeks during sleep and any daytime during the day. Each participant and caregiver will be guided by the study physician to use Katz Index of Independence in Activities of Daily Living (ADL) to measure the level of life independence. The study physician will perform neurological examination. Stroke Impact Scale (SIS) for stroke-specific health status measurement, SF-36 questionnaires (SF-36) to measure life quality, Electroencephalography (EEG) test, and Bio-Well energy test, will be conducted respectively at the baseline, 2 or 4 weeks after the study treatment. SIS and SF-36 questionnaires will be recalled 4 weeks before the baseline for each participant.
Comparator and mode of administration The same shape, size, and weight of the device without generating biophoton is to be labelled with individual codes and used as a comparator. The comparator device will be placed in the same way as the Treatment device in the hotel room during the designed study period.
Study duration Estimated date of the first participant enrolled: May 2023. The estimated date of the last patient completed: December 2023. The participants randomized in the Control group will be switched to the Treatment after observing the placebo effects for four weeks. They will be treated with the active device for 4-weeks for self-comparison analysis.
Duration of treatment Participants in the Control and Treatment Groups will actively participate in the study for 4-weeks. Each participant and caregiver will answer the standard study questionnaires at the baseline, 2 or 4 weeks of the study, respectively. The participants randomized in the Control will participate in the study for a total of 6 weeks.
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. All patients with chronic stroke will participate in the live-in observational study by sleeping on Tesla MedBed in a special hotel.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Biophoton Energizing Brain and Whole BodyActive Biophoton Generators are placed under the hotel bed. |
| Control Group | Placebo comparator | Device: Biophoton Energizing Brain and Whole BodyPlacebo-products are placed under the hotel bed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be 18-years or older and can live in a hotel
- Must have a caregiver willing to support the participant's full involvement in the study and can assist to complete all study questionnaires
- Can provide informed consent (maybe assisted by Caregiver)
- Has evidence of a clinical diagnosis of stroke occurred at least 6 months ago.
- Has a disability unable to be living independently per Caregiver
Key exclusion criteria (4 listed)
- Untreated psychiatric disturbances that would affect trial participation as judged by the Caregiver or by the clinical study medical professional
- Who relies on ventilators
- 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, kidney failure, etc.
- 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 |
|---|---|---|
| Biophoton Energizing Brain and Whole BodyThe patient is to be energized within a strong biophoton field which is constantly generated by active biophoton generators. | Device | Control Group, Treatment Group |
Primary outcome
Regain Life Independence by Normalizing Activities of Daily Living (ADL).
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
If the damaged brain is repaired, the participant can perform daily activities.
4 secondary outcomes
Neurologic Examination Using a Standard Neurologic Exam Form to Measure Neurologic Function
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Stroke Impact Scale (SIS) to Reflect Paralysis Status Change (fully recovery =300)
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Brain injury status detected with EEG (electroencephalogram).
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Life Quality Improvement Measured with a Standard SF-36 Questionnaire
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No. All individual participants' identification information will be kept confidential. All data report forms will have the subject number. The study report and scientific publication will not show any identifiable information of the patient.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biophoton Energizing Brain and Whole Body in people with Chronic Stroke, 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 7 inclusion and 4 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regain Life Independence by Normalizing Activities of Daily Living (ADL). (time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.). 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.