Biophoton therapy for patients with brain disorders
Impact of a Biophoton Therapy on Patients With Brain Disorders
This study is testing if a special light therapy can help people with brain disorders like Alzheimer's and Parkinson's feel better while they stay at a treatment center for a few weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Institute of All Medicines Academic / other |
| Locations | 1 site (Butler, Pennsylvania) |
| Trial ID | NCT06147999 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of biophoton therapy on patients suffering from various brain disorders, including Alzheimer's disease, dementia, Parkinson's disease, and traumatic brain injury. Participants will stay at the Tesla MedBed Center for 4 to 6 weeks, where they will be randomly assigned to either a treatment group receiving biophoton generators or a placebo group. The study employs a triple-blinded, placebo-controlled design to ensure the validity of the results, with participants using the assigned devices during sleep for the first two weeks. After this period, participants may be switched to the treatment group based on their initial assignment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a clinical diagnosis of a brain disorder and a supportive caregiver.
Not a fit: Patients with untreated mental illnesses, those relying on ventilators, or individuals with implanted electronic devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel and effective treatment option for patients with debilitating brain disorders.
How similar studies have performed: Previous studies have shown promising results for biophoton therapy in treating brain disorders, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Can provide a clinical diagnosis of a brain disorder. * Can complete all study procedures during the study. * Must be fluent in English (or the Caregiver can fully translate). * Women of childbearing age must provide results of a pregnancy test in order to participate. Exclusion Criteria: * 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. * Is participating in another investigational drug or device trial. * Has an active infectious disease, such as COVID-19. * Pregnant women.
Where this trial is running
Butler, Pennsylvania
- Tesla MedBed Center, 139 Pittsburgh Road, Butler, PA 16001 — Butler, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.