Skip to main content
OpenTrials
Completed

NCT Number: NCT02118805

Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Immune System Diseases Metabolic Diseases Motor Neuron Disease Movement Disorders Muscular Diseases Musculoskeletal Diseases Myasthenia Gravis Myopathies Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Nutritional and Metabolic Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Parkinson Disease Parkinson's Disease Parkinsonian Disorders Proteostasis Deficiencies Spinal Cord Diseases Stroke Synucleinopathies TDP-43 Proteinopathies Vascular Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. 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

    Participants with neurological conditions will answer questions about swallowing

  2. 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

    Participants with neurological conditions will be asked to repeat "pepper" and "ticker" ten times as quickly as possible

  3. 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

    Participants with neurological conditions will be asked to perform this task if safe

  4. 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

    Participants who have been diagnosed with ALS will answer questions about function, including speech and swallowing

  5. 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

    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

  6. 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

    Participants who have been diagnosed with Parkinson's Disease will be asked questions about function, including speech and swallowing

  7. 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

    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

  8. 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

    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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Acronym: QUESST

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2014
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.