Measurement of the Distribution of Optical Properties in Adult Human Muscle

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Muscle Weakness Conditions
Cachexia
Hypothermia
Vascular Occlusion
Device: Diffuse Optical Spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measurement of the Distribution of Optical Properties in Adult Human Muscle

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 140
Study Start Date: October 2004
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Diffuse Optical Spectroscopy
    Muscle properties
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic, community sample

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540683

Contacts
Contact: Montana Compton, R.N 949-824-9265 mocomton@uci.edu

Locations
United States, California
Beckman Laser Institute University of California Irvine Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, R.N    949-824-9265    mocomton@uci.edu   
Principal Investigator: Albert Cerussi, Ph.D         
Sub-Investigator: Bruce J Tromberg, Ph.D         
Sub-Investigator: Montana Compton, RN         
Sub-Investigator: Amanda Durkin, BS         
Sub-Investigator: Robert Warren, BS         
Sub-Investigator: Goutham Ganesan, BS         
Sub-Investigator: Thomas O'Sullivan, PhD         
Sub-Investigator: Anais Leproux, Ph.D.         
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Albert Cerussi, Ph.D Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540683     History of Changes
Other Study ID Numbers: LAMMP DOS-RR-01192-50
Study First Received: October 4, 2007
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Muscle tissue change before and after exercise
Muscle tissue change related to chemotherapy
Muscle tissue change related to cold and hot temperature
Muscle tissue change related to diabetic

Additional relevant MeSH terms:
Cachexia
Hypothermia
Muscle Weakness
Paresis
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Body Temperature Changes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014