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Far Infrared Irradiation for Managing and Treating Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT00674934
Recruitment Status : Unknown
Verified January 2009 by GAAD Medical Research Institute Inc..
Recruitment status was:  Active, not recruiting
First Posted : May 8, 2008
Last Update Posted : January 5, 2009
Sponsor:
Information provided by:
GAAD Medical Research Institute Inc.

Tracking Information
First Submitted Date  ICMJE May 6, 2008
First Posted Date  ICMJE May 8, 2008
Last Update Posted Date January 5, 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 7, 2008)
Treatment of MS [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00674934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2008)
Rehabilitation of MS 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 Managing and Treating Multiple Sclerosis (MS)
Official Title  ICMJE Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for Multiple Sclerosis.
Brief Summary Multiple sclerosis (abbreviated MS) is an autoimmune condition in which the immune system attacks the central nervous system (CNS), leading to demyelination. This study will investigate the use of far infrared radiation for MS control, management and treatment.
Detailed Description

MS a demyelinating disease, is any disease of the nervous system in which the myelin sheath of neurons is damaged. This impairs the conduction of signals in the affected nerves, causing impairment in sensation, movement, cognition, or other functions depending on which nerves are involved.

MS affects the areas of the brain and spinal cord known as the white matter. White matter cells carry signals between the grey matter areas, where the processing is done, and the rest of the body. More specifically, MS destroys oligodendrocytes which are the cells responsible for creating and maintaining a fatty layer, known as the myelin sheath, which helps the neurons carry electrical signals.

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 MS.

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 Multiple Sclerosis
Intervention  ICMJE Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
Far Infrared Radiation (5μm to 20μm wavelength). Far Infrared radiation for 30 to 40 minutes per treatment session.
Other Name: Far Infrared Radiation
Study Arms  ICMJE Experimental: 1
Radiation
Intervention: Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
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
Estimated Enrollment  ICMJE
 (submitted: May 7, 2008)
5
Original Estimated Enrollment  ICMJE Same as current
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 MS

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 NCT00674934
Other Study ID Numbers  ICMJE GAAD-MS-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 & 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 January 2009

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