Chronic Stroke Clinical Trial
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.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Tesla MedBed Center at Butler-PA | Butler | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
First Institute of All Medicines |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Regain Life Independence by Normalizing Activities of Daily Living (ADL). | If the damaged brain is repaired, the participant can perform daily activities. | 0-2 weeks, 0-4 weeks after starting the study treatment. | |
Secondary | Neurologic Examination Using a Standard Neurologic Exam Form to Measure Neurologic Function | The study physician will conduct the standardized neurologic examinations | 0-2 weeks, 0-4 weeks after starting the study treatment. | |
Secondary | Stroke Impact Scale (SIS) to Reflect Paralysis Status Change (fully recovery =300) | Under study physician's guidance, participant will answer the standard questionnaires. | 0-2 weeks, 0-4 weeks after starting the study treatment. | |
Secondary | Brain injury status detected with EEG (electroencephalogram). | Brain injury exists at the baseline and can be repaired with biophotons. | 0-2 weeks, 0-4 weeks after starting the study treatment. | |
Secondary | Life Quality Improvement Measured with a Standard SF-36 Questionnaire | Using Short Form Health Survey (SF-36) to measure life quality. | 0-2 weeks, 0-4 weeks after starting the study treatment. |
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