Trial record 19 of 193 for:    Primary Lateral Sclerosis

Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders (QUESST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Beth Israel Deaconess Medical Center
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT02118805
First received: April 8, 2014
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition
Amyotrophic Lateral Sclerosis (ALS)
Myasthenia Gravis
Myopathies
Stroke
Parkinson's Disease

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Quantitative Ultrasonography and Electrical Impedance Myography: Speech and Swallowing Technologies for Use in Neurological Disorders

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Change in Muscle Health over 18 months by Standard Ultrasound [ Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 ] [ Designated as safety issue: No ]
    Selected muscles of the face, limbs, trunk, and tongue will be visualized with painless, non-invasive ultrasound; this measure will be performed in healthy volunteers and participants with neurological conditions

  • Change in Muscle Health by Specialized Electrical Impedance Arrays [ Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 ] [ Designated as safety issue: No ]
    Selected muscles of the face, limbs, trunk, and tongue will be measured using painless, specialized electrode arrays; this measure will be performed in healthy volunteers and participants with neurological conditions


Secondary Outcome Measures:
  • Change in Score on the Sydney Swallow Questionnaire (over 18 months) [ Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 ] [ Designated as safety issue: No ]
    Participants with neurological conditions will answer questions about swallowing

  • Change in Number of Seconds It takes to Repeat Individual Words Ten Times (over 18 months) [ Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 ] [ Designated as safety issue: No ]
    Participants with neurological conditions will be asked to repeat "pepper" and "ticker" ten times as quickly as possible

  • Change in Number of Seconds It Takes to Swallow of 3 ounces of Water (over 18 months) [ Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 ] [ Designated as safety issue: No ]
    Participants with neurological conditions will be asked to perform this task if safe

  • Change in Score on the Amyotrophic Lateral Sclerosis Rating Scale - Revised (ALSFRS-R) (over 18 months) [ Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 ] [ Designated as safety issue: No ]
    Participants who have been diagnosed with ALS will answer questions about function, including speech and swallowing

  • Change in Score on the Quantitative Myasthenia Gravis Scale (over 18 months) [ Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 ] [ Designated as safety issue: No ]
    Participants who have been diagnosed with Myasthenia Gravis will be asked to perform certain tasks, such as raising the arm, and the findings will be scored by a research team member

  • Change in Score on the United Parkinson's Disease Rating Scale (UPDRS) (over 18 months) [ Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 ] [ Designated as safety issue: No ]
    Participants who have been diagnosed with Parkinson's Disease will be asked questions about function, including speech and swallowing

  • Change in Muscle Health by Standard Concentric Needle Electromyography (EMG) (over 18 months) [ Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 ] [ Designated as safety issue: No ]
    Participants who have been diagnosed with ALS will be asked if they are willing to participate in standard needle EMG of selected muscles of the face and tongue


Estimated Enrollment: 200
Study Start Date: October 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with ALS
Patients with Myasthenia Gravis
Patients with Muscle Disease
Patients with Stroke
Patients with Parkinson's Disease
Healthy Volunteers

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
  • Age 20-90 years

Exclusion Criteria:

  • History or presence of a medical condition that substantially impacts bulbar function
  • Age under 20 or over 90 years
  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: NCT02118805

Contacts
Contact: Sung Yim (617)-667-3053 syim1@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Seward B Rutkove, MD         
Sub-Investigator: Courtney E McIlduff, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Seward Rutkove, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02118805     History of Changes
Other Study ID Numbers: 2013-P-000204/1
Study First Received: April 8, 2014
Last Updated: April 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
ALS
Myasthenia Gravis
Myopathy
Stroke
Parkinson's Disease
Bulbar
Orofacial
Ultrasound
Electrical Impedance Myography

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Muscular Diseases
Myasthenia Gravis
Nervous System Diseases
Parkinson Disease
Stroke
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Musculoskeletal Diseases
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Autoimmune Diseases
Immune System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Movement Disorders
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014