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Impact of Biophoton Generator on Chronic-Stroke Patients' Recovery

Primary Purpose

Chronic Stroke, Paralysis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Biophoton Generators
Inactive Biophoton Generators
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

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Stroke Impact Scale (SIS)
The SIS is a stroke-specific, self-report, health status measure. It was designed to assess multidimensional stroke outcomes, including strength, hand function, mobility, communication, emotion, memory and thinking, and participation.
Change in Brain Injury Status
Brain injury status is to be detected by using an EEG to measure frequency bands of Gamma, BETA, ALPHA THETA, and DELTA.
Change in Life Quality Measured with Short Form Health Survey (SF-36)
Measure the quality of life as influenced by the investigational medical device. The range of SF-36 scores are from 0 (worst) to 100 (best).

Full Information

First Posted
May 23, 2023
Last Updated
June 8, 2023
Sponsor
First Institute of All Medicines
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1. Study Identification

Unique Protocol Identification Number
NCT05898334
Brief Title
Impact of Biophoton Generator on Chronic-Stroke Patients' Recovery
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
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
December 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Outcome Variables 1. Primary Outcome Measure: Regain Life Independence by Normalizing Activities of Daily Living (ADL). Life 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. 2. Secondary Outcome Measure: Neurological Examination by a Study Physician. [Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment]. Stroke Impact Scale (SIS). [Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment]. The SIS is a stroke-specific, self-report, health status measure. It was designed to assess multidimensional stroke outcomes, including strength, hand function, mobility, communication, emotion, memory and thinking, and participation. Brain function change is detected by using an FDA-cleared EEG machine. Short Form Health Survey (SF-36) [Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment] to measure the quality of life as influenced by the investigational medical device (an OTC device). SF-36 has been used worldwide as a standard clinical research tool for many years. Energy Level of the Brain. The brain and the other organs, and meridians of the participants will be measured by using Bio-Well GDV Camera device and calculated by multiplication of area on average intensity on correction coefficient. [Time Frame: 0-2 weeks, 0-4 weeks after starting the study treatment]. Safety Outcome: Occurrence of adverse events (AE). Any AE was reported by participants and caregiver. [Time Frame: Any AE occurred at the baseline, at 2-weeks and then at 4-weeks.] Any reported AE will be tabulated and compared between the two groups.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active Biophoton Generators
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Inactive Biophoton Generators
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Activities of Daily Living (ADL)
Description
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.
Time Frame
0-2 weeks, 0-4 weeks after starting the study treatment.
Secondary Outcome Measure Information:
Title
Change in Stroke Impact Scale (SIS)
Description
The SIS is a stroke-specific, self-report, health status measure. It was designed to assess multidimensional stroke outcomes, including strength, hand function, mobility, communication, emotion, memory and thinking, and participation.
Time Frame
0-2 weeks, 0-4 weeks after starting the study treatment.
Title
Change in Brain Injury Status
Description
Brain injury status is to be detected by using an EEG to measure frequency bands of Gamma, BETA, ALPHA THETA, and DELTA.
Time Frame
0-2 weeks, 0-4 weeks after starting the study treatment.
Title
Change in Life Quality Measured with Short Form Health Survey (SF-36)
Description
Measure the quality of life as influenced by the investigational medical device. The range of SF-36 scores are from 0 (worst) to 100 (best).
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
James Millen, D.C.
Phone
3023539873
Email
james.millen@firstallmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariola Smotrys, MD, MBA, MSc
Organizational Affiliation
First Institute of All Medicines
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Z Liu, MD, PhD
Organizational Affiliation
First Institute of All Medicines
Official's Role
Study Chair
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
James Millen, D.C.
Phone
3023539873
Email
james.millen@firstallmed.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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. Clinical study report will be issued without exposing individual identification information.
IPD Sharing Time Frame
3 Years
IPD Sharing 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.
IPD Sharing URL
http://firstallmed.org

Learn more about this trial

Impact of Biophoton Generator on Chronic-Stroke Patients' Recovery

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