Measurement of the Distribution of Optical Properties in Adult Human Muscle

This study is currently recruiting participants.
Verified December 2013 by University of California, Irvine
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00540683
First received: October 4, 2007
Last updated: December 9, 2013
Last verified: December 2013

October 4, 2007
December 9, 2013
October 2004
July 2016   (final data collection date for primary outcome measure)
Measurement of the Distribution of Optical Properties in Adult Human Muscle [ Time Frame: upto 12 months ] [ Designated as safety issue: No ]
Measurement of the Distribution of Optical Properties in Adult Human Muscle
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Complete list of historical versions of study NCT00540683 on ClinicalTrials.gov Archive Site
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Measurement of the Distribution of Optical Properties in Adult Human Muscle
Measurement of the Distribution of Optical Properties in Adult Human Muscle

At Beckman Laser Institute, University of California,Irvine. We have developed a diagnostic device use Near-Infrared Tissue Optics as a means to monitor muscle physiology, for example during exercise or in response to external factors such as shock.

The red to near-infrared (NIR) part of the electromagnetic spectrum (600 to 1000 nm) allows photons to penetrate a few centimeters below the surface of the skin. These photons are non-ionizing and do not induce local heating. Quantitative optical spectroscopy in the NIR allows for safe, non-invasive measurements of the concentrations of blood, water, and lipids in tissues.

Diffuse Optical Spectroscopy (DOS) has been in use for clinical studies(UCI HS#1995-563, HS#2002-2306), These studies have clearly shown the enormous sensitivity of DOS to hemodynamic events in tissues. These hemodynamic parameters have been shown to correlate with invasive measures of cardiac output, mean arterial pressure, blood loss, and blood hemoglobin concentration. Thus the DOS signal is more representative of the perfusion of blood and consumption of oxygen in the muscle.

Hypotheses;

The optical properties of muscle vary with age, gender, and muscle fitness level. NIR optical scattering and total hemoglobin concentration are both expected to decrease with age and increase with muscle fitness level.

The application of a two-layer model to the muscle/fat layer system will improve the reliability of DOS measurements over the standard homogenous model.

Changes in optical properties are indicative of response to exercise training

  1. Short term changes include increases in hemoglobin and water
  2. Long term changes include lesser increases in hemoglobin and tissue scattering

Muscle tissues that display cachexia will display optical properties that are significantly lower than those of muscle tissues in normal subjects.

Cellulite will have a different effect on light transmission than "normal" adipose tissues.

Changes in tissue oxygenation and metabolism can be quantified using DOS during alterations in deep tissue temperature.

Procedure;

Measurement sites for this study will include major muscle groups in the arms, legs and abdomen/back. The optical measurement consists of placing a pen shape probe onto the surface of the body. The optical probe consists of optical fibers and a plastic holder. Total measurement time will be less than 20 minutes.

Anticipate Risk and Benefit;

Near-infrared light does not ionize biological tissue and poses no significant health risk. The measurement is painless, and no discomfort. There are however, risks that are currently unforeseeable.

There are no direct benefits to participants in this protocol. Results from this research will be used to develop devices that would be beneficial to others in sports medicine and critical care medicine.

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

primary care clinic, community sample

  • Muscle Weakness Conditions
  • Cachexia
  • Hypothermia
  • Vascular Occlusion
Device: Diffuse Optical Spectroscopy
Muscle properties
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
July 2016
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or Female age 18 years and older
  • Diagnosed of Cachexic condition
  • Diagnosed of Cellulite adult female 18 years and older

Exclusion Criteria:

  • Pregnant women
  • Taking light sensitive drugs for use in photodynamic therapy
Both
18 Years to 75 Years
Yes
Contact: Montana Compton, R.N 949-824-9265 mocomton@uci.edu
United States
 
NCT00540683
LAMMP DOS-RR-01192-50
No
Montana Compton, University of California, Irvine
Montana Compton
Beckman Laser Institute University of California Irvine
Principal Investigator: Albert Cerussi, Ph.D Beckman Laser Institute University of California Irvine
University of California, Irvine
December 2013

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