Biophotonizer - a Biophoton Genera… for Parkinson's (NCT06147999)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 3 years.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- You will have testing visits at baseline, 2 weeks, and 4 weeks after the study treatment.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain wave recording (EEG) (non-invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.