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Trial record 65 of 520 for:    ALS (Amyotrophic Lateral Sclerosis)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00673140
Recruitment Status : Unknown
Verified August 2009 by GAAD Medical Research Institute Inc..
Recruitment status was:  Active, not recruiting
First Posted : May 7, 2008
Last Update Posted : August 17, 2009
Sponsor:
Information provided by:
GAAD Medical Research Institute Inc.

Tracking Information
First Submitted Date  ICMJE May 6, 2008
First Posted Date  ICMJE May 7, 2008
Last Update Posted Date August 17, 2009
Study Start Date  ICMJE May 2008
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2008)
Therapy for ALS [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00673140 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2008)
Rehabilitation of ALS patients [ Time Frame: 2 Years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Far Infrared Irradiation for Control, Management and Treatment of Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
    Radiation: Far Infrared Radiation (5μm to 20μm wavelength). Far Infrared radiation for 30 to 40 minutes per treatment session.
    Other Name: Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
  • Radiation: Far infrared radiation
    Far infrared radiation at a frequency of 5 microns to 20 microns for 30 to 40 minutes per session.
Study Arms  ICMJE Experimental: 1
Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
Interventions:
  • Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
  • Radiation: Far infrared radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 14, 2009)
7
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2008)
5
Estimated Study Completion Date  ICMJE June 2010
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with ALS

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00673140
Other Study ID Numbers  ICMJE GAAD-ALS-CTP1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Kwasi Donyina/Founder and President, GAAD Medical Research Institute Inc.
Study Sponsor  ICMJE GAAD Medical Research Institute Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ken Nedd, M.D. GAAD Medical Research Institute Inc.
PRS Account GAAD Medical Research Institute Inc.
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP