Impact of Biophoton Generator on Chronic-Stroke Patients' Recovery

NCT05898334 | Completed FDA Device

• 2 other identifiers: FIAM-CS-2022#2022/09/27
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical research is to verify if the patients 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. The main study questions are:

• Can patients with chronic stroke regain life independence by normalizing Activities of Daily Living (ADL).
• Can brain-injury and recovery status of the patients with chronic stroke be detected by using an EEG machine. Participants will sleep-rest on a hotel bed energized by Tesla BioHealing Biophoton Generators, and clinical study staff will observe the participant's activities of daily living, as compared to those who will sleep in the hotel room equipped with placebo devices.

Conditions

Chronic Stroke; Paralysis

Keywords

stroke, paralysis

Outcome Measures

Primary Outcomes (1)

• Change in Activities of Daily Living (ADL)

  Regain Life Independence by Normalizing Activities of Daily Living (ADL). Independence is defined as the normalization of activities of daily living (ADL), at which time the participant's total ADL score will be increased at least to 4 from the baseline score of 2 or less. The participant, the caregiver, together with a study physician can make the judgment if she/he can independently perform the daily activity at any time during the study period.

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

Secondary Outcomes (3)

• Change in Stroke Impact Scale (SIS)

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

• Change in Brain Injury Status

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

• Change in Life Quality Measured with Short Form Health Survey (SF-36)

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

Study Arms (2)

Treatment

EXPERIMENTAL

Active biophoton generators will be placed under the hotel bed to be used by the participant who is randomized to the Treatment Group and activities of daily living will be observed for 4 weeks.

Device: Active Biophoton Generators

Control

PLACEBO COMPARATOR

Placebo biophoton generators will be placed under the hotel bed to be used by the participant who is randomized to the Control Group and activities of daily living will be observed for 4 weeks.

Device: Inactive Biophoton Generators

Interventions

Active Biophoton Generators DEVICE

The whole body, including brain, of the study participant will be sleeping inside of the strong biophoton field so her/his entire body will be energized to promote self-healing.

Treatment

Inactive Biophoton Generators DEVICE

The whole body, including brain, of the study participant will be sleeping inside of the normal hotel bed and the participant will not receive any biophotons.

Control

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

Paralysis; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mariola Smotrys, MD, MBA, MSc

  First Institute of All Medicines

  PRINCIPAL INVESTIGATOR

• James Z Liu, MD, PhD

  First Institute of All Medicines

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each qualified patient to receive a coded subject number and the same code-matched product. Other than the Informed Consent form, all study information will be recorded by using the coded subject number. Before the blinded statistical report is issued, no one knows the type of the study products - either a positive or a placebo product.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The biostatistician will prepare a randomization schedule including a serial of subject numbers/product codes. Each placebo or treatment product will be individually labeled with a code. The study coordinator will randomly assign each qualified patient to receive a coded subject number and the same code-matched product. Other than the Informed Consent form, all study information will be recorded by using the coded subject number. The Principal Investigator, study physicians, study coordinator, study specialist, data-entry specialist, biostatistician, as well as the participant and caregiver, will be blinded about who received the placebo or treatment product. At the end of the 4-week study, the participants in the Control Group can be treated with the active device for 4 weeks to observe the efficacy. Their data will be used for a self-comparison analysis.

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 12, 2023
• Study Start: May 10, 2023
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 Years
• Access Criteria: Authorized representatives of the Study-Organizer, a regulatory authority, an Ethics Committee may visit the study site to perform audits or inspections, including source data verification.

Locations

US (1)