Biophoton Therapy for Stroke

Overseen By Mariola Smotrys, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: First Institute of All Medicines

Disqualifiers: Psychiatric disturbances, Ventilator use, others

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

46 Participants Needed

Trial Summary

What is the purpose of this trial?

Study objective The purpose of this clinical research is to verify if the patient with chronic stroke can regain the ability of living independently after daily using Testa BioHealing® Biophoton Generators to increase the energy of the brain and other parts of the body. Study design This study is a randomized, triple-blinded, placebo-controlled prospective intervention clinical research. At least 46 patients with chronic stroke will participate in the live-in observational study in a Tesla MedBed Center. Study patient population The adult patient with a chronic stroke which was defined as a stroke occurred at least 6 months ago with a significant disability unable to have an independent life, is to be considered as a qualified participant.

Eligibility Criteria

This trial is for adults who had a stroke at least 6 months ago and now need help to live independently. They must have a caregiver, be able to give consent (with assistance if needed), speak English or have translation, not use ventilators, and not have severe illnesses that could affect the study.

Inclusion Criteria

Must have a caregiver willing to support the participant's full involvement in the study and can assist to complete all study questionnaires

Can provide informed consent (maybe assisted by Caregiver)

I can attend all required study visits and procedures.

Exclusion Criteria

You have mental health issues that are not being treated and could affect your ability to take part in the trial, according to the study doctor or caregiver.

Is participating in another investigational drug or device trial

You need a ventilator to help you breathe.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either active or placebo biophoton generators for 8 hours daily during sleep and any daytime for 4 weeks

4 weeks

Baseline, 2 weeks, 4 weeks (in-person)

Control Group Crossover

Participants in the Control group switch to active treatment for self-comparison analysis

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Biophoton Generators

Trial Overview The trial tests if Testa BioHealing® Biophoton Generators can help chronic stroke patients regain independence by energizing the brain and body. It's randomized and triple-blinded, meaning neither researchers nor participants know who gets real treatment or placebo.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

Active Biophoton Generators are placed under the hotel bed.

Group II: Control Group Placebo Group 1 Intervention

Placebo-products are placed under the hotel bed.

Who Is Running the Clinical Trial?

First Institute of All Medicines

Lead Sponsor

Trials

4

Recruited

220+