Can Patients With Chronic Stroke Regain Living Independence by Daily Energizing With Biophoton Generators

NCT06049849 | Completed FDA Device

• 1 other identifier: 2022/09/27
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Stroke

Keywords

stroke, paralysis

Outcome Measures

Primary Outcomes (1)

• Regain Life Independence by Normalizing Activities of Daily Living (ADL).

  If the damaged brain is repaired, the participant can perform daily activities.

  0-2 weeks, 0-4 weeks after starting the study treatment.

Secondary Outcomes (4)

• Neurologic Examination Using a Standard Neurologic Exam Form to Measure Neurologic Function

  0-2 weeks, 0-4 weeks after starting the study treatment.

• Stroke Impact Scale (SIS) to Reflect Paralysis Status Change (fully recovery =300)

  0-2 weeks, 0-4 weeks after starting the study treatment.

• Brain injury status detected with EEG (electroencephalogram).

  0-2 weeks, 0-4 weeks after starting the study treatment.

• Life Quality Improvement Measured with a Standard SF-36 Questionnaire

  0-2 weeks, 0-4 weeks after starting the study treatment.

Study Arms (2)

Treatment Group

EXPERIMENTAL

Active Biophoton Generators are placed under the hotel bed.

Device: Biophoton Energizing Brain and Whole Body

Control Group

PLACEBO COMPARATOR

Placebo-products are placed under the hotel bed.

Device: Biophoton Energizing Brain and Whole Body

Interventions

Biophoton Energizing Brain and Whole Body DEVICE

The patient is to be energized within a strong biophoton field which is constantly generated by active biophoton generators.

Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18-years or older and can live in a hotel
• 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)
• Has evidence of a clinical diagnosis of stroke occurred at least 6 months ago.
• Has a disability unable to be living independently per Caregiver
• Can complete all study procedures during the study
• Must be fluent in English (or the Caregiver can fully translate)

You may not qualify if:

• Untreated psychiatric disturbances that would affect trial participation as judged by the Caregiver or by the clinical study medical professional
• Who relies on ventilators
• 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, kidney failure, etc.
• Is participating in another investigational drug or device trial

Sponsors & Collaborators

• First Institute of All Medicines: lead

Study Sites (1)

Tesla MedBed Center at Butler-PA

Butler, Pennsylvania, 16001, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All products are individual coded. All other visible characters are identical.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized, triple-blinded, placebo-controlled prospective intervention clinical research. All patients with chronic stroke will participate in the live-in observational study by sleeping on Tesla MedBed in a special hotel.

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 22, 2023
• Study Start: October 31, 2023
• Primary Completion: October 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 8, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)