Chronic StrokeNCT05898334
Impact of Biophoton Generator on Chronic-Stroke Patients' Recovery
A study testing Active Biophoton Generators and Inactive Biophoton Generators in people with Chronic Stroke and Paralysis, run by First Institute of All Medicines at 1 site in United States.
Trial summary
The purpose of this clinical research is to verify if the patients 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, Paralysis
- What is being tested?
- Active Biophoton Generators and Inactive Biophoton Generators
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2023to 28 Jun 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
The purpose of this clinical research is to verify if the patients 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. The main study questions are:
- Can patients with chronic stroke regain life independence by normalizing Activities of Daily Living (ADL).
- Can brain-injury and recovery status of the patients with chronic stroke be detected by using an EEG machine.
Participants will sleep-rest on a hotel bed energized by Tesla BioHealing Biophoton Generators, and clinical study staff will observe the participant's activities of daily living, as compared to those who will sleep in the hotel room equipped with placebo devices.
Read the detailed description
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.
Outcome Variables
- Primary Outcome Measure: Regain Life Independence by Normalizing Activities of Daily Living (ADL). Life Independence is defined as the normalization of activities of daily living (ADL), at which time the participant's total ADL score will be increased at least to 4 from the baseline score of 2 or less. The participant, the caregiver, together with a study physician can make the judgment if she/he can independently perform the daily activity at any time during the study period.
- Secondary Outcome Measure:
- Neurological Examination by a Study Physician. [Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment].
- Stroke Impact Scale (SIS). [Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment]. The SIS is a stroke-specific, self-report, health status measure. It was designed to assess multidimensional stroke outcomes, including strength, hand function, mobility, communication, emotion, memory and thinking, and participation.
- Brain function change is detected by using an FDA-cleared EEG machine.
- Short Form Health Survey (SF-36) [Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment] to measure the quality of life as influenced by the investigational medical device (an OTC device). SF-36 has been used worldwide as a standard clinical research tool for many years.
- Energy Level of the Brain. The brain and the other organs, and meridians of the participants will be measured by using Bio-Well GDV Camera device and calculated by multiplication of area on average intensity on correction coefficient. [Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment].
Safety Outcome: Occurrence of adverse events (AE). Any AE was reported by participants and caregiver. [Time Frame: Any AE occurred at the baseline, at 2-weeks and then at 4-weeks.] Any reported AE will be tabulated and compared between the two groups.
- Conditions
- Chronic Stroke, Paralysis
- Being tested
- Active Biophoton Generators, Inactive Biophoton Generators
- Keywords
- stroke, paralysis
- Medical subject headings
- Paralysis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Biophoton GeneratorsDevice
The whole body, including brain, of the study participant will be sleeping inside of the strong biophoton field so her/his entire body will be energized to promote self-healing.
Inactive Biophoton GeneratorsDevice
The whole body, including brain, of the study participant will be sleeping inside of the normal hotel bed and the participant will not receive any biophotons.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Active biophoton generators will be placed under the hotel bed to be used by the participant who is randomized to the Treatment Group and activities of daily living will be observed for 4 weeks. Receives: Device: Active Biophoton Generators |
| Control | Placebo comparator | Placebo biophoton generators will be placed under the hotel bed to be used by the participant who is randomized to the Control Group and activities of daily living will be observed for 4 weeks. Receives: Device: Inactive Biophoton Generators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Activities of Daily Living (ADL)
Regain Life Independence by Normalizing Activities of Daily Living (ADL). Independence is defined as the normalization of activities of daily living (ADL), at which time the participant's total ADL score will be increased at least to 4 from the baseline score of 2 or less. The participant, the caregiver, together with a study physician can make the judgment if she/he can independently perform the daily activity at any time during the study period.
Measured: 0-2 weeks, 0-4 weeks after starting the study treatment.
Secondary outcomes (3)
Change in Stroke Impact Scale (SIS)
The SIS is a stroke-specific, self-report, health status measure. It was designed to assess multidimensional stroke outcomes, including strength, hand function, mobility, communication, emotion, memory and thinking, and participation.
Measured: 0-2 weeks, 0-4 weeks after starting the study treatment.
Change in Brain Injury Status
Brain injury status is to be detected by using an EEG to measure frequency bands of Gamma, BETA, ALPHA THETA, and DELTA.
Measured: 0-2 weeks, 0-4 weeks after starting the study treatment.
Change in Life Quality Measured with Short Form Health Survey (SF-36)
Measure the quality of life as influenced by the investigational medical device. The range of SF-36 scores are from 0 (worst) to 100 (best).
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 posted12 Jun 2023
- Study start10 May 2023
- Primary completion28 Jun 2024
- Study completion28 Jun 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
- The biostatistician will prepare a randomization schedule including a serial of subject numbers/product codes. Each placebo or treatment product will be individually labeled with a code. The study coordinator will randomly assign each qualified patient to receive a coded subject number and the same code-matched product. Other than the Informed Consent form, all study information will be recorded by using the coded subject number. The Principal Investigator, study physicians, study coordinator, study specialist, data-entry specialist, biostatistician, as well as the participant and caregiver, will be blinded about who received the placebo or treatment product. At the end of the 4-week study, the participants in the Control Group can be treated with the active device for 4 weeks to observe the efficacy. Their data will be used for a self-comparison analysis.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Institute of All Medicines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariola Smotrys, MD, MBA, MSc, Principal investigator, First Institute of All MedicinesJames Z Liu, MD, PhD, Study chair, First Institute of All Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898334
- Sponsor's protocol ID
- FIAM-CS-2022
- Other IDs
- #2022/09/27
- Status last verified
- Jun 2024
- First submitted
- 23 May 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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. Clinical study report will be issued without exposing individual identification information.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. 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
- NCT05898334
- Acronym / sponsor ID
- FIAM-CS-2022
- Conditions
- Chronic Stroke, Paralysis
- Keywords
- stroke, paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- First Institute of All MedicinesUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 12 Jun 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.
The purpose of this clinical research is to verify if the patients 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. The main study questions are:
- Can patients with chronic stroke regain life independence by normalizing Activities of Daily Living (ADL).
- Can brain-injury and recovery status of the patients with chronic stroke be detected by using an EEG machine.
Participants will sleep-rest on a hotel bed energized by Tesla BioHealing Biophoton Generators, and clinical study staff will observe the participant's activities of daily living, as compared to those who will sleep in the hotel room equipped with placebo devices.
Detailed description
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.
Outcome Variables
- Primary Outcome Measure: Regain Life Independence by Normalizing Activities of Daily Living (ADL). Life Independence is defined as the normalization of activities of daily living (ADL), at which time the participant's total ADL score will be increased at least to 4 from the baseline score of 2 or less. The participant, the caregiver, together with a study physician can make the judgment if she/he can independently perform the daily activity at any time during the study period.
- Secondary Outcome Measure:
- Neurological Examination by a Study Physician. [Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment].
- Stroke Impact Scale (SIS). [Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment]. The SIS is a stroke-specific, self-report, health status measure. It was designed to assess multidimensional stroke outcomes, including strength, hand function, mobility, communication, emotion, memory and thinking, and participation.
- Brain function change is detected by using an FDA-cleared EEG machine.
- Short Form Health Survey (SF-36) [Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment] to measure the quality of life as influenced by the investigational medical device (an OTC device). SF-36 has been used worldwide as a standard clinical research tool for many years.
- Energy Level of the Brain. The brain and the other organs, and meridians of the participants will be measured by using Bio-Well GDV Camera device and calculated by multiplication of area on average intensity on correction coefficient. [Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment].
Safety Outcome: Occurrence of adverse events (AE). Any AE was reported by participants and caregiver. [Time Frame: Any AE occurred at the baseline, at 2-weeks and then at 4-weeks.] Any reported AE will be tabulated and compared between the two groups.
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
- The biostatistician will prepare a randomization schedule including a serial of subject numbers/product codes. Each placebo or treatment product will be individually labeled with a code. The study coordinator will randomly assign each qualified patient to receive a coded subject number and the same code-matched product. Other than the Informed Consent form, all study information will be recorded by using the coded subject number. The Principal Investigator, study physicians, study coordinator, study specialist, data-entry specialist, biostatistician, as well as the participant and caregiver, will be blinded about who received the placebo or treatment product. At the end of the 4-week study, the participants in the Control Group can be treated with the active device for 4 weeks to observe the efficacy. Their data will be used for a self-comparison analysis.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Active Biophoton GeneratorsActive biophoton generators will be placed under the hotel bed to be used by the participant who is randomized to the Treatment Group and activities of daily living will be observed for 4 weeks. |
| Control | Placebo comparator | Device: Inactive Biophoton GeneratorsPlacebo biophoton generators will be placed under the hotel bed to be used by the participant who is randomized to the Control Group and activities of daily living will be observed for 4 weeks. |
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 |
|---|---|---|
| Active Biophoton GeneratorsThe whole body, including brain, of the study participant will be sleeping inside of the strong biophoton field so her/his entire body will be energized to promote self-healing. | Device | Treatment |
| Inactive Biophoton GeneratorsThe whole body, including brain, of the study participant will be sleeping inside of the normal hotel bed and the participant will not receive any biophotons. | Device | Control |
Primary outcome
Change in Activities of Daily Living (ADL)
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Regain Life Independence by Normalizing Activities of Daily Living (ADL). Independence is defined as the normalization of activities of daily living (ADL), at which time the participant's total ADL score will be increased at least to 4 from the baseline score of 2 or less. The participant, the caregiver, together with a study physician can make the judgment if she/he can independently perform the daily activity at any time during the study period.
3 secondary outcomes
Change in Stroke Impact Scale (SIS)
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Change in Brain Injury Status
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Change in Life Quality Measured with Short Form Health Survey (SF-36)
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 1 Jul 2024.
- Individual participant dataSharing planned: Yes. 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. Clinical study report will be issued without exposing individual identification information.
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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.
Mariola Smotrys, MD, MBA, MSc principal investigator
First Institute of All Medicines
James Z Liu, MD, PhD study chair
First Institute of All Medicines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Biophoton Generators and Inactive Biophoton Generators in people with Chronic Stroke and Paralysis, 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 1 Jul 2024. 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?
Change in 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 1 Jul 2024.