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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Unknown status

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Far Infrared Radiation (5μm to 20μm wavelength)

Far infrared radiation

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with ALS

Exclusion Criteria:

None

Sites / Locations

The Centre for Incurable Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Radiation: Far Infrared Radiation (5μm to 20μm wavelength)

Outcomes

Primary Outcome Measures

Therapy for ALS

Secondary Outcome Measures

Rehabilitation of ALS patients

Full Information

NCT ID

NCT00673140

First Posted

May 6, 2008

Last Updated

August 14, 2009

Sponsor

GAAD Medical Research Institute Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00673140

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2008 (undefined)

Primary Completion Date

May 2010 (Anticipated)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

GAAD Medical Research Institute Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Radiation: Far Infrared Radiation (5μm to 20μm wavelength)

Intervention Type

Radiation

Intervention Name(s)

Far Infrared Radiation (5μm to 20μm wavelength)

Other Intervention Name(s)

Radiation: Far Infrared Radiation (5μm to 20μm wavelength)

Intervention Description

Radiation: Far Infrared Radiation (5μm to 20μm wavelength). Far Infrared radiation for 30 to 40 minutes per treatment session.

Intervention Type

Radiation

Intervention Name(s)

Far infrared radiation

Intervention Description

Far infrared radiation at a frequency of 5 microns to 20 microns for 30 to 40 minutes per session.

Primary Outcome Measure Information:

Title

Therapy for ALS

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Rehabilitation of ALS patients

Time Frame

2 Years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with ALS Exclusion Criteria: None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ken Nedd, M.D.

Organizational Affiliation

GAAD Medical Research Institute Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Centre for Incurable Diseases

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4V 1L5

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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