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Characterization of Familial Myopathy and Paget Disease of Bone

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01166854
First received: July 20, 2010
Last updated: December 26, 2012
Last verified: December 2012
History of Changes

July 20, 2010
December 26, 2012
June 2010
June 2015   (final data collection date for primary outcome measure)
muscle disease [ Time Frame: 1 week ] [ Designated as safety issue: No ]
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.

The DOS 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
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

primary care clinic
  • Muscle Disorder
  • Bone Disorder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
25
June 2015
June 2015   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01166854
LAMMP-30139; HS#2007-5832
No
Montana Compton, University of California, Irvine
Montana Compton
Not Provided
Principal Investigator: Bruce Tromberg, PhD Beckman Laser Institute University of California Irvine
University of California, Irvine
December 2012

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