Far Infrared Irradiation for Control, Management and Treatment of Amyotrophic Lateral Sclerosis (ALS)

Study Overview
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Brief Summary
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Amyotrophic Lateral Sclerosis (ALS, sometimes called Lou Gehrig's s Disease, or Maladie de Charcot) is a progressive, usually fatal, neurodegenerative disease caused by the degeneration of motor neurons, the nerve cells in the central nervous system that control voluntary muscle movement. This study will investigate the use of far infrared radiation for the control, management and treatment of ALS.

Detailed Description
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As a motor neuron disease, ALS causes muscle weakness and atrophy throughout the body as both the upper and lower motor neurons degenerate, ceasing to send messages to muscles. Unable to function, the muscles gradually weaken, develop fasciculations (twitches) because of denervation, and eventually atrophy due to that denervation. The patient may ultimately lose the ability to initiate and control all voluntary movement except of the eyes. Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells. It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have ALS.

Official Title
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Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for the Control, Management and Treatment of Amyotrophic Lateral Sclerosis (ALS) or Lou Gehrig's Disease

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
* Radiation: Far infrared radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ALS Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Radiation: Far Infrared Radiation (5μm to 20μm wavelength) | Radiation: Far Infrared Radiation (5μm to 20μm wavelength)<br>* Radiation: Far Infrared Radiation (5μm to 20μm wavelength). Far Infrared radiation for 30 to 40 minutes per treatment session.<br>* Other names: Radiation: Far Infrared Radiation (5μm to 20μm wavelength);Radiation: Far infrared radiation<br>* Far infrared radiation at a frequency of 5 microns to 20 microns for 30 to 40 minutes per session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy for ALS |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehabilitation of ALS patients |  | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALS (Amyotrophic Lateral Sclerosis), Amyotrophic Lateral Sclerosis With Dementia, Amyotrophic Lateral Sclerosis, Guam Form, Dementia With Amyotrophic Lateral Sclerosis, Gehrig's Disease, Guam Form of Amyotrophic Lateral Sclerosis, Lou Gehrig Disease