About this trial
Previous clinical studies revealed that the newly developed biophoton therapy has been safe and effective in treating patients with Alzheimer's disease, dementia, stroke, traumatic brain injury, or Parkinson's disease. The current study is to confirm the previous clinical observation by conducting as a randomized, triple-blinded, placebo-controlled prospective intervention clinical research. About 80 patients with brain disorder (Alzheimer's disease, dementia, stroke, traumatic brain injury, Parkinson's disease) will participate in the intervention clinical study at the Tesla MedBed Center located in Butler, PA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must meet conditions for approval.
Must be 18-years or older and stay in a hotel.
Must have a caregiver willing to support the participant's full involvement in the study. • The caregiver can assist in completing all study surveys.
Can provide informed consent or can be assisted by caregiver.
Disqualifiers
Any untreated mental illnesses, that would affect study participation. This will be judged by the caregiver, or by the clinical study medical expert.
Someone that relies on a ventilator.
Someone who has a deep brain stimulator, pacemaker, or any implanted electronic devices.
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, severe diabetes, kidney failure, or any end-of-life prognosis.
Trial design
Parallel
Treatments tested in this trial
Biophotonizer - a Biophoton Generator
DeviceA biophotonizer is a device producing strong biophoton field. These biophotons help the human body to gain self-healing capacity to heal many disorders, including brain disorders.
Treatment groups
Trial outcomes
Primary outcomes
Overall Life Quality impacted by Biophoton Therapy
Short Form Health Survey (SF-36) will be used to assess life quality: scored from 0 (worst health) to 100 (best heath).
Cognitive Capacity impacted by Biophoton Therapy
Montreal Cognitive Assessment (MOCA), Score below 10, severe cognition damage; 26-30, normal cognition.
Secondary outcomes
Neurological Examination impacted by Biophoton Therapy
Neurological Examination by a Study Physician. The higher the score, the healthier the participant.
Brain function change impacted by Biophoton Therapy
Brain function change is to be detected by using an EEG machine. Eye reaction time - the shorter the healthier.
Brain Bio-Energy impacted by Biophoton Therapy
Using Bio-Well GDV Camera device and calculated by multiplication of areas of the brain. The more balanced joules, the better brain energy.
Blood Circulation impacted by Biophoton Therapy
FALCON QUAD measures circulation using the ankle-brachial index. The more balanced measurement, the better blood circulation.
Other outcomes
Safety of the Study participant impacted by Biophoton Therapy
Number of participants with treatment-related adverse events as assessed by CTCAEv4.0
Sponsors and contacts
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