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

Primary Purpose

Chronic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biophoton Energizing Brain and Whole Body
Sponsored by
First Institute of All Medicines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring stroke, paralysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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

Sites / Locations

  • Tesla MedBed Center at Butler-PARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Control Group

Arm Description

Active Biophoton Generators are placed under the hotel bed.

Inactive Biophoton Generators are placed under the hotel bed.

Outcomes

Primary Outcome Measures

Regain Life Independence by Normalizing Activities of Daily Living (ADL).
If the damaged brain is repaired, the participant can perform daily activities.

Secondary Outcome Measures

Neurologic Examination Using a Standard Neurologic Exam Form to Measure Neurologic Function
The study physician will conduct the standardized neurologic examinations
Stroke Impact Scale (SIS) to Reflect Paralysis Status Change (fully recovery =300)
Under study physician's guidance, participant will answer the standard questionnaires.
Brain injury status detected with EEG (electroencephalogram).
Brain injury exists at the baseline and can be repaired with biophotons.
Life Quality Improvement Measured with a Standard SF-36 Questionnaire
Using Short Form Health Survey (SF-36) to measure life quality.

Full Information

First Posted
September 11, 2023
Last Updated
September 16, 2023
Sponsor
First Institute of All Medicines
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1. Study Identification

Unique Protocol Identification Number
NCT06049849
Brief Title
Can Patients With Chronic Stroke Regain Living Independence by Daily Energizing With Biophoton Generators
Official Title
Can Participants With Chronic Stroke Regain Living Independence by Daily Energizing With a Biophoton Generator
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Institute of All Medicines

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Investigational product and mode of administration The hotel bed is powered by a standardized set of 14 biophoton generators of 32-Oz size, which was previously tested as safe and effective. The active device is FDA registered over-the-counter (OTC) medical device. The device can be used by anyone who wants to increase blood circulation and reduce bodily pains, according to the label claims. For this study, the active or inactive devices will be labeled with individual codes. The participant, caregiver and the study staff cannot know if the hotel room is equipped with a set of active or inactive devices. When the participant is lying on the hotel bed, she/he may or may not receive biophotons. The study physician, participant or the caregiver will record the ADL and other changes, and answer the standard study questionnaires at the baseline, 2, or 4 weeks after study treatment, respectively. Study procedure Each of all participants assigned to the Control or Treatment Group will be continually treated with the current standard of care (SOC), if any. The Control group will use the coded placebo devices, and the Treatment Group will use the coded treatment product. All coded products will be packed with the same container with the same size and weight. Each participant will use the Treatment or Control device at least for 8-hours every day for 4-weeks during sleep and any daytime during the day. Each participant and caregiver will be guided by the study physician to use Katz Index of Independence in Activities of Daily Living (ADL) to measure the level of life independence. The study physician will perform neurological examination. Stroke Impact Scale (SIS) for stroke-specific health status measurement, SF-36 questionnaires (SF-36) to measure life quality, Electroencephalography (EEG) test, and Bio-Well energy test, will be conducted respectively at the baseline, 2 or 4 weeks after the study treatment. SIS and SF-36 questionnaires will be recalled 4 weeks before the baseline for each participant. Comparator and mode of administration The same shape, size, and weight of the device without generating biophoton is to be labelled with individual codes and used as a comparator. The comparator device will be placed in the same way as the Treatment device in the hotel room during the designed study period. Study duration Estimated date of the first participant enrolled: May 2023. The estimated date of the last patient completed: December 2023. The participants randomized in the Control group will be switched to the Treatment after observing the placebo effects for four weeks. They will be treated with the active device for 4-weeks for self-comparison analysis. Duration of treatment Participants in the Control and Treatment Groups will actively participate in the study for 4-weeks. Each participant and caregiver will answer the standard study questionnaires at the baseline, 2 or 4 weeks of the study, respectively. The participants randomized in the Control will participate in the study for a total of 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
stroke, paralysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All products are individual coded. All other visible characters are identical.
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Active Biophoton Generators are placed under the hotel bed.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Inactive Biophoton Generators are placed under the hotel bed.
Intervention Type
Device
Intervention Name(s)
Biophoton Energizing Brain and Whole Body
Intervention Description
The patient is to be energized within a strong biophoton field which is constantly generated by active biophoton generators.
Primary Outcome Measure Information:
Title
Regain Life Independence by Normalizing Activities of Daily Living (ADL).
Description
If the damaged brain is repaired, the participant can perform daily activities.
Time Frame
0-2 weeks, 0-4 weeks after starting the study treatment.
Secondary Outcome Measure Information:
Title
Neurologic Examination Using a Standard Neurologic Exam Form to Measure Neurologic Function
Description
The study physician will conduct the standardized neurologic examinations
Time Frame
0-2 weeks, 0-4 weeks after starting the study treatment.
Title
Stroke Impact Scale (SIS) to Reflect Paralysis Status Change (fully recovery =300)
Description
Under study physician's guidance, participant will answer the standard questionnaires.
Time Frame
0-2 weeks, 0-4 weeks after starting the study treatment.
Title
Brain injury status detected with EEG (electroencephalogram).
Description
Brain injury exists at the baseline and can be repaired with biophotons.
Time Frame
0-2 weeks, 0-4 weeks after starting the study treatment.
Title
Life Quality Improvement Measured with a Standard SF-36 Questionnaire
Description
Using Short Form Health Survey (SF-36) to measure life quality.
Time Frame
0-2 weeks, 0-4 weeks after starting the study treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Jackson
Phone
3029222486
Email
jessica.jackson@firstallmed.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mariola Smotrys, M.D.
Phone
3025003010
Email
mariola.smotrys@firstallmed.org
Facility Information:
Facility Name
Tesla MedBed Center at Butler-PA
City
Butler
State/Province
Pennsylvania
ZIP/Postal Code
16001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Jackson
Phone
302-922-2486
Email
jessica.jackson@firstallmed.org
First Name & Middle Initial & Last Name & Degree
Mariola Smotrys, M.D.
Phone
3025003010
Email
mariola.smotrys@firstallmed.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All individual participants' identification information will be kept confidential. All data report forms will have the subject number. The study report and scientific publication will not show any identifiable information of the patient.

Learn more about this trial

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

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