What side effects are associated with this type of intervention?

Common treatments for paralysis include physical therapy, medications, and surgical interventions. Physical therapy generally has minimal side effects but can cause muscle soreness and fatigue. Medications such as muscle relaxants and pain relievers can lead to drowsiness, dizziness, and gastrointestinal issues. Surgical interventions carry risks of infection, bleeding, and complications related to anesthesia. Treatments similar to Testa BioHealing® Biophoton Generators, which aim to increase energy in the brain and body, are less well-documented in terms of side effects. However, non-invasive energy-based therapies generally have minimal side effects, though some patients may experience temporary discomfort or skin irritation.

What prior FDA approvals exist?

The provided context does not mention any FDA-approved treatments specifically similar to the Testa BioHealing® Biophoton Generators, which aim to increase the energy of the brain and body. However, FDA-approved treatments for paralysis often include interventions like diaphragm pacing for respiratory insufficiency and various forms of botulinum toxin injections for muscle spasticity. These treatments focus on improving muscle function and managing symptoms rather than directly increasing brain or body energy.

What other types of research exist?

Promising novel alternatives for paralysis patients include: 1) Photobiomodulation using diffusing optical fibers to project light energy directly onto the spinal cord surface, 2) In vivo NeuroD1-mediated astrocyte-to-neuron conversion for neuronal regeneration, 3) Scaffold-facilitated neuronal relay formation to promote motor function recovery, and 4) Sustained delivery of dbcAMP via poly(propylene carbonate) micron fibers to promote axonal regenerative sprouting and functional recovery.

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Biophoton Generator

Biophoton Therapy for Stroke Recovery

N/A

Waitlist Available

Led By Mariola Smotrys, MD, MBA, MSc

Research Sponsored by First Institute of All Medicines

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Summary

This trial is testing if a special light-emitting device can help chronic stroke patients regain independence in daily activities. The device is used during sleep to see if it boosts brain and body energy levels, aiding recovery.

Who is the study for?

This trial is for adults over 18 with chronic stroke, who can't live independently and have had a stroke at least 6 months ago. They need a caregiver to help with the study and must be able to stay in a hotel. Participants or their caregivers should understand English. Those on ventilators, in other trials, or with severe health issues that could affect the study can't join.

What is being tested?

The trial tests if Testa BioHealing® Biophoton Generators can help chronic-stroke patients regain independence by improving brain energy and daily functions compared to placebo devices. Patients will use these generators while sleeping in a hotel bed, and their recovery will be monitored.

What are the potential side effects?

Since this trial involves non-invasive biophoton generators rather than drugs, traditional side effects are not expected. However, any unexpected reactions related to the device's use will be closely monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-2 weeks, 0-4 weeks after starting the study treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Activities of Daily Living (ADL)

Secondary study objectives

Change in Brain Injury Status

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

Change in Stroke Impact Scale (SIS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

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.

Group II: ControlPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active Biophoton Generators

2023

N/A

~50

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for paralysis include physical therapy, neuromuscular electrical stimulation (NMES), and innovative therapies like biophoton generators. Physical therapy works by improving muscle strength and coordination through repetitive exercises. NMES involves electrical impulses to stimulate muscle contractions, enhancing muscle function and potentially aiding in neural recovery. Biophoton generators, such as the Testa BioHealing® devices, aim to increase cellular energy and promote healing by emitting biophotons that may enhance cellular communication and repair. These treatments are crucial for paralysis patients as they can improve functional status, increase independence, and enhance overall quality of life.

A review of stroke rehabilitation and physiotherapy.The effect of additional neuromuscular electrical stimulation applied to erector spinae muscles on functional capacity, balance and mobility in post-stroke patients.Therapeutic potential of PEGylated insulin-like growth factor I for skeletal muscle disease evaluated in two murine models of muscular dystrophy.