Characterization of Familial Myopathy and Paget Disease of Bone

Muscle Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01166854
• Other study ID #: NIH/LAMMP-2007-5832
• Status: Recruiting
• Start date: June 18, 2010
• Est. completion date: June 2022

Study information

• Verified date: April 2021
• Source: University of California, Irvine
• Contact: Marie Wencel, BS
• Phone: 949-824-0521
• Email: mwencel[@]uci.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Bone Disorder
• Disease
• Muscle Disorder
• Muscular Diseases

Intervention

Device:
• Diffuse Optical Spectroscopy
Diffuse Optical Spectroscopy

Locations

Country	Name	City	State
United States	Beckman Laser Institute Medical clinic	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle disease		1 week