Impact of Biophoton Generator on Chronic-Stroke Patients' Recovery
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ClinicalTrials.gov Identifier: NCT05898334 |
Recruitment Status :
Recruiting
First Posted : June 12, 2023
Last Update Posted : June 12, 2023
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Tracking Information | |||||||||||||||||||||
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First Submitted Date ICMJE | May 23, 2023 | ||||||||||||||||||||
First Posted Date ICMJE | June 12, 2023 | ||||||||||||||||||||
Last Update Posted Date | June 12, 2023 | ||||||||||||||||||||
Actual Study Start Date ICMJE | May 10, 2023 | ||||||||||||||||||||
Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
Change History | No Changes Posted | ||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||
Brief Title ICMJE | Impact of Biophoton Generator on Chronic-Stroke Patients' Recovery | ||||||||||||||||||||
Official Title ICMJE | Can Participants With Chronic Stroke Regain Living Independence by Daily Energizing With a Biophoton Generator | ||||||||||||||||||||
Brief 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. The main study questions are:
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. |
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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 1. 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. 2. Secondary Outcome Measure:
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. |
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Study Type ICMJE | Interventional | ||||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: 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. Before the blinded statistical report is issued, no one knows the type of the study products - either a positive or a placebo product. Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||
Estimated Enrollment ICMJE |
46 | ||||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||||||||||||||||
Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||||||||
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Administrative Information | |||||||||||||||||||||
NCT Number ICMJE | NCT05898334 | ||||||||||||||||||||
Other Study ID Numbers ICMJE | FIAM-CS-2022 #2022/09/27 ( Other Identifier: IRB ) |
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Has Data Monitoring Committee | No | ||||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | First Institute of All Medicines | ||||||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||||||
Current Study Sponsor ICMJE | First Institute of All Medicines | ||||||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||||
Investigators ICMJE |
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PRS Account | First Institute of All Medicines | ||||||||||||||||||||
Verification Date | May 2023 | ||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |