Quantitative Ultrasonography and Electrical Impedance Myography: Speech and Swallowing Technologies for Use in Neurological Disorders

Study Purpose:

This study is evaluating the use of two painless, non-invasive technologies in the assessment of muscle health over time in both healthy volunteers and patients who have diseases that affect the nervous system.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Healthy Volunteer, Healthy Volunteer with a Family History of ALS

Study Type:

Observational Study

Study Category:

Diseases, Study Type, Study Status, Phase, Gender

Study Status:

Active, currently recruiting

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Seward Rutkove, MD Beth Israel Deaconess Medical Center

Clinicaltrials.gov ID (11 digit #):

NCT02118805

Neals Affiliated?

No

Coordinating Center Contact Information

Beth Israel Deaconess Medical Center
Sung Yim / .(JavaScript must be enabled to view this email address) / (617)-667-3053
.(JavaScript must be enabled to view this email address) Boston, Massachusetts 02215 United States

Full Study Summary:

Speech and swallowing abnormalities are important symptoms associated with disorders of the central nervous system, motor neuron disease (such as amyotrophic lateral sclerosis), myasthenia gravis, and primary muscle conditions. In addition to characterizing the evolution in muscle architecture that could underlie associated orofacial weakness, identifying new ways to measure these abnormalities is critical to the development and testing of novel treatment approaches. As painless, non-invasive, portable technologies, quantitative ultrasonography (QUS) and electrical impedance myography (EIM) could meet the need for objective measures of speech and swallowing dysfunction.

In QUS, acoustic energy is applied to a muscle of interest; the resultant pictorial data are translated into a single value that reflects the health of the imaged muscle. Similarly, in EIM, a high-frequency, low-intensity alternating electrical current is applied to individual muscles, and the resulting voltages measured. Impedance values reflect changes in muscle architecture, including fiber atrophy, inflammation, and the replacement of muscle with fat or connective tissue. Both of these user-friendly methods can provide sensitive indicators of neuromuscular disease status when applied to the limbs. Although they have also been used to evaluate orofacial muscles in healthy volunteers and patients with primary muscle disorders, they have not yet been systematically studied in patients with a range of neurological conditions.

When applied to muscles of the face and tongue, such tools could 1. Improve accuracy of early diagnosis; 2. Allow monitoring of speech and swallowing dysfunction over time; 3. Help individualize care; and 4. Serve as biomarkers in clinical trials. We propose that QUS and EIM will provide convenient, reliable, clinically meaningful surrogate markers of orofacial dysfunction in a variety of neurologic conditions.

Study Sponsor:

Beth Israel Deaconess Medical Center

Participant Duration:

Estimated Enrollment:

200

Estimated Study Start Date:

09/30/2013

Estimated Study Completion Date:

05/31/2017

Posting Last Modified Date:

11/02/2016

Date Study Added to alsconsortium.org:

08/19/2015
  • More Information
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    20

    Maximum Age:

    90

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    Study Population
    Patients will be recruited principally from the BIDMC outpatient clinics and inpatient ward service. Healthy volunteers will be recruited through online advertising.
    Criteria

    Inclusion Criteria:
    -Established, or clinically probable, neurologic diagnosis with at least the potential for associated bulbar dysfunction

    Exclusion Criteria:
    -History or presence of a medical condition that substantially impacts bulbar function

  • Site Contact Information

    Beth Israel Deaconess Medical Center
    Sung Yim / .(JavaScript must be enabled to view this email address) / (617)-667-3053
    Boston, Massachusetts 02215
    United States