An interventional study of Active Biophoton Generators and Inactive Biophoton Generators in Chronic Stroke and Paralysis, sponsored by First Institute of All Medicines. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by First Institute of All Medicines · Not applicable, Interventional, and Treatment
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.
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
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →First Institute of All Medicines is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Active Biophoton Generators
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.
Device: Inactive Biophoton Generators
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.
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.
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.
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
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.
Time frame: 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.
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)
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).
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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First Institute of All Medicines