Tesla MedBed Center, 139 Pittsburgh Road, Butler, PA 16001
Butler, Pennsylvania, 16001, United States
Location status: Recruiting
NCT Number: NCT06147999
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Butler, Pennsylvania, 16001, United States
Location status: Recruiting
The participant will live in the hotel-like research center for 4 weeks, or 6 weeks if the participants are randomly placed in a placebo group. The initial 2 weeks of participation is triple blinded to record the placebo effects, as each set of the study device is labelled with a unique code for use by only one participant. The change of the placebo device to the treatment device will be performed by the study device management team staff who will not inform the study participant nor study research staff who involve study data collection. Each participant assigned to the Control Group will be treated with 14 placebo devices under the bed plus two placebo devices to place in bed on each side of the head. Each participant assigned to the Treatment Group will receive 14 Biophoton generator devices under the bed plus two Biophoton Generators to place in bed on each side of the head. Each participant will use the Treatment or Control device for at least 8 hours every night for the first 2 weeks during sleep. During the day, participants are welcome to move around the facility, visit people or places. At the end of the first 2 weeks, the study participants will be advised whether she/he will be continually in a treatment group for 2 more weeks or be switched from a placebo group to a treatment group for 4 more weeks. Each participant will be guided by study team staff on their assigned testing day to answer the standard SF-36 questionnaires (SF-36) for measuring life quality, Cognitive Improvement Questionnaires, physician performed neurologic examination, Bio-well energy test, the Electroencephalography (EEG) test, blood flow test, and brain biophoton test, respectively at the baseline, 2 and 4 weeks after the study treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 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.
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Short Form Health Survey (SF-36) will be used to assess life quality: scored from 0 (worst health) to 100 (best heath).
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Montreal Cognitive Assessment (MOCA), Score below 10, severe cognition damage; 26-30, normal cognition.
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Neurological Examination by a Study Physician. The higher the score, the healthier the participant.
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Brain function change is to be detected by using an EEG machine. Eye reaction time - the shorter the healthier.
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Using Bio-Well GDV Camera device and calculated by multiplication of areas of the brain. The more balanced joules, the better brain energy.
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
FALCON QUAD measures circulation using the ankle-brachial index. The more balanced measurement, the better blood circulation.
Time frame: 0-2 weeks, 0-4 weeks after starting the study treatment.
Number of participants with treatment-related adverse events as assessed by CTCAEv4.0
Interested in participating?
Request InfoFirst Institute of All Medicines
Other
Acronym: Alzheimer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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