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Characterization of Familial Myopathy and Paget Disease of Bone

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ClinicalTrials.gov Identifier: NCT01166854
Recruitment Status : Recruiting
First Posted : July 21, 2010
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):

July 20, 2010
July 21, 2010
February 10, 2017
June 2010
June 2018   (Final data collection date for primary outcome measure)
muscle disease [ Time Frame: 1 week ]
Same as current
Complete list of historical versions of study NCT01166854 on ClinicalTrials.gov Archive Site
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Characterization of Familial Myopathy and Paget Disease of Bone
Phase 1 Study Non-invasive Use Diffuse Optical Spectroscopy Will Measure the Concentrations of Blood, Water, and Lipids (Fats, for Example) in Tissues

The researcher wants to explore the genetic causes of muscle disease. The researcher is particularly interested in muscle disorders that occur in combination with diseases of bone that appear to be passed on from generation to generation.

Diffuse Optical Spectroscopy will measure the concentrations of blood, water, and lipids (fats, for example) in your tissues. This device essentially measures the color of tissues in order to determine tissue physiology (its physical and chemical processes).

Diffuse Optical Spectroscopy, the technique is fast and painless and was developed at the University of California, Irvine. The Diffuse Optical Spectroscopy instrument is actively involved in research studies, but is not yet a part of routine clinical practice. The result of this study will aid similar research projects that seek to improve our understanding of how tissues work and how alterations in metabolism affect long-term health.

TheDiffuse Optical Spectroscopy measurement consists of placing a probe onto the surface of your body (calf, bicep, or head). This probe will be secured by either gentle hand pressure or fastened to your skin using clinically-approved wraps such as Coban/wrap bandages or medical adhesive tape and medical glues. Several dots will be made on your skin outlining the probe with a surgical felt tip marker. This is so we would be able to put the probe again on the same spot in case we needed to interrupt the measurement. The probe looks like a bar code scanner in a supermarket and it shines infrared light on your skin. There is no radiation involved with this light. In some cases where light signals are low, the optical detector will be placed directly onto your skin (but contained within an electronically shielded casing, and placed inside another plastic casing). (not offered during pregnancy).

Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Study Population will be selected from Dr. Kimonis outpatient clinic at University of California Irvine.
  • Muscle Disorder
  • Bone Disorder
Device: Diffuse Optical Spectroscopy
Diffuse Optical Spectroscopy
Muscle weakness
Diffuse Optical Spectroscopy
Intervention: Device: Diffuse Optical Spectroscopy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2018
June 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria: Male or Female age 18 and older

  • diagnose of Muscle or bone disorders
  • with a combination of medical problems including muscle and bone disease and their family members.

Exclusion Criteria:

  • under 18 year of age
  • unrelated diagnosis
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Marie Wencel, BS 949-824-0521 mwencel@uci.edu
United States
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Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
Beckman Laser Institute University of California Irvine
Principal Investigator: Virginia Kimonis, MD Beckman Laser Institute University of California Irvine
Study Director: Bruce Tromberg, PhD Beckman Laser Institute University of California Irvine
University of California, Irvine
February 2017