Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-28 @ 12:00 AM
Study NCT ID:
NCT05898334
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2023-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Biophoton Generator on Chronic-Stroke Patients' Recovery
Sponsor:
First Institute of All Medicines
Organization:
Study Overview
Official Title:
Can Participants With Chronic Stroke Regain Living Independence by Daily Energizing With a Biophoton Generator
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
* 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.
* 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
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:
1. Neurological Examination by a Study Physician. \[Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment\].
2. 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.
3. Brain function change is detected by using an FDA-cleared EEG machine.
4. 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.
5. 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.
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:
1. Neurological Examination by a Study Physician. \[Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment\].
2. 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.
3. Brain function change is detected by using an FDA-cleared EEG machine.
4. 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.
5. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| #2022/09/27 | OTHER | IRB | View |