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Characterization of Familial Myopathy and Paget Disease of Bone

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. Identifier: NCT01166854
Recruitment Status : Suspended (Pending IRB approval)
First Posted : July 21, 2010
Last Update Posted : February 25, 2019
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Brief Summary:

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).

Condition or disease Intervention/treatment
Muscle Disorder Bone Disorder Device: Diffuse Optical Spectroscopy

Detailed Description:

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).

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase 1 Study Non-invasive Use Diffuse Optical Spectroscopy Will Measure the Concentrations of Blood, Water, and Lipids (Fats, for Example) in Tissues
Study Start Date : June 2010
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Group/Cohort Intervention/treatment
Muscle weakness
Diffuse Optical Spectroscopy
Device: Diffuse Optical Spectroscopy
Diffuse Optical Spectroscopy

Primary Outcome Measures :
  1. muscle disease [ Time Frame: 1 week ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study Population will be selected from Dr. Kimonis outpatient clinic at University of California Irvine.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01166854

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United States, California
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
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Principal Investigator: Virginia Kimonis, MD Beckman Laser Institute University of California Irvine
Study Director: Bruce Tromberg, PhD Beckman Laser Institute University of California Irvine
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Responsible Party: Beckman Laser Institute and Medical Center, Virginia Kimonis, MD, MRCP, University of California, Irvine Identifier: NCT01166854    
Other Study ID Numbers: NIH/LAMMP-2007-5832
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
muscle and bone disease
Additional relevant MeSH terms:
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Bone Diseases
Muscular Diseases
Pathologic Processes
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases