Test biophoton therapy for tremor
- Trial ID
- NCT06147999
- Official Title
- Impact of a Biophoton Therapy on Patients With Brain Disorders
- Goal
- Test biophoton therapy for tremor
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- First Institute of All Medicines
- Study Type
- INTERVENTIONAL
- Enrollment
- 80 participants
- Conditions
- Brain Disorders - Alzheimer's Disease, Dementia, Parkinson's Disease, Traumatic Brain Injury
- Interventions
- Biophotonizer - a Biophoton Generator
Summary For Families
Researchers want to see whether a handheld Biophotonizer light treatment can change brain function or symptoms in people with brain disorders, including Parkinson's, by promoting cellular signaling and lowering harmful inflammation. The approach uses a non-drug device that emits very low intensity biophoton light aimed at stimulating neurons and repair pathways, and it is given during an in-person hotel stay while participants keep their usual medications rather than replacing levodopa. Adults 18 and older with a clinical diagnosis of a brain disorder who can stay in a hotel and bring a caregiver to help with visits and surveys can join. People with implanted electronic devices like DBS or pacemakers, those on ventilators, with unstable medical conditions, active infections, pregnancy, or enrolled in another investigational trial are excluded.
Locations
- Tesla MedBed Center, 139 Pittsburgh Road, Butler, PA 16001, Butler, Pennsylvania, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Biophotonizer - a Biophoton Generator. Researchers want to see whether a handheld Biophotonizer light treatment can change brain function or symptoms in people with brain disorders, including Parkinson's, by promoting cellular signaling and lowering harmful inflammation. The approach uses a non-drug device that emits very low intensity biophoton light aimed at stimulating neurons and repair pathways, and it is given during an in-person hotel stay while participants keep their usual medications rather than replacing levodopa. Adults 18 and older with a clinical diagnosis of a brain disorder who can stay in a hotel and bring a caregiver to help with visits and surveys can join. People with implanted electronic devices like DBS or pacemakers, those on ventilators, with unstable medical conditions, active infections, pregnancy, or enrolled in another investigational trial are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 3 years.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.