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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 6, 2008 | ||||
| Last Updated Date | January 2, 2009 | ||||
| Start Date ICMJE | May 2008 | ||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Treatment of people with HD [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00675077 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Rehabilitation of people with HD [ Time Frame: 2 Years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Far Infrared Irradiation for Managing, Control and Treatment of Huntington's Disease (HD) | ||||
| Official Title ICMJE | Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for Control, Management and Treatment of HD | ||||
| Brief Summary | Huntington's disease (HD) is a fatal disease with profound neurological and behavioral features. HD is typically characterized by uncontrollable movements and psychological disturbances. This study will investigate the use of far infrared radiation for control, management and treatment of HD. |
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| Detailed Description | 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 HD. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Huntington Disease | ||||
| Intervention ICMJE | Radiation: Far Infrared Radiation | ||||
| Study Arms / Comparison Groups | Experimental: Radiation: Far Infrared Radiation (5μm to 20μm wavelength) | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 5 | ||||
| Estimated Completion Date | June 2010 | ||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00675077 | ||||
| Responsible Party | Dr. Kwasi Donyina/Founder & President, GAAD Medical Research Institute Inc. | ||||
| Study ID Numbers ICMJE | GAAD-HD-CTP1 | ||||
| Study Sponsor ICMJE | GAAD Medical Research Institute Inc. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GAAD Medical Research Institute Inc. | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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