Amyotrophic Lateral Sclerosis (ALS)QUESSTNCT02118805
Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders
An observational study of Amyotrophic Lateral Sclerosis (ALS) and Myasthenia Gravis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS), Myasthenia Gravis, Myopathies
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited principally from the BIDMC outpatient clinics and inpatient ward service. Healthy volunteers will be recruited through online advertising.
Who may be able to join
- Established, or clinically probable, neurologic diagnosis with at least the potential for associated bulbar dysfunction
- Age 20-90 years
Who cannot join
- History or presence of a medical condition that substantially impacts bulbar function
- Age under 20 or over 90 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Quantitative Ultrasonography and Electrical Impedance Myography: Speech and Swallowing Technologies for Use 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.
Read the detailed description
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.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Myasthenia Gravis, Myopathies, Stroke, Parkinson's Disease
- Keywords
- ALS, Myasthenia Gravis, Myopathy, Stroke, Parkinson's Disease, Bulbar, Orofacial, Ultrasound, Electrical Impedance Myography
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Myasthenia Gravis, Muscular Diseases, Stroke, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ALS | No intervention is used in this study. The health of muscle is monitored over time. | |
| Patients with Myasthenia Gravis | No intervention is used in this study. The health of muscle is monitored over time. | |
| Patients with Muscle Disease | No intervention is used in this study. The health of muscle is monitored over time. | |
| Patients with Stroke | No intervention is used in this study. The health of muscle is monitored over time. | |
| Patients with Parkinson's Disease | No intervention is used in this study. The health of muscle is monitored over time. | |
| Healthy Volunteers | No intervention is used in this study. The health of muscle is monitored over time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Health over 18 months by Standard Ultrasound
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
Measured: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Secondary outcomes (8)
Change in Score on the Sydney Swallow Questionnaire (over 18 months)
Participants with neurological conditions will answer questions about swallowing
Measured: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in Number of Seconds It takes to Repeat Individual Words Ten Times (over 18 months)
Participants with neurological conditions will be asked to repeat "pepper" and "ticker" ten times as quickly as possible
Measured: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in Number of Seconds It Takes to Swallow of 3 ounces of Water (over 18 months)
Participants with neurological conditions will be asked to perform this task if safe
Measured: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in Score on the Amyotrophic Lateral Sclerosis Rating Scale - Revised (ALSFRS-R) (over 18 months)
Participants who have been diagnosed with ALS will answer questions about function, including speech and swallowing
Measured: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in Score on the Quantitative Myasthenia Gravis Scale (over 18 months)
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
Measured: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in Score on the United Parkinson's Disease Rating Scale (UPDRS) (over 18 months)
Participants who have been diagnosed with Parkinson's Disease will be asked questions about function, including speech and swallowing
Measured: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in Muscle Health by Standard Concentric Needle Electromyography (EMG) (over 18 months)
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
Measured: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in Muscle Health by Specialized Electrical Impedance Arrays
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
Measured: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startOct 2013
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seward Rutkove, Beth Israel Deaconess Medical Center
- Investigators
- Seward Rutkove, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118805
- Sponsor's protocol ID
- 2013P000204
- Acronym
- QUESST
- Status last verified
- Apr 2023
- First submitted
- 8 Apr 2014
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Ultrasonography and Electrical Impedance Myography: Speech and Swallowing Technologies for Use in Neurological Disorders
- ClinicalTrials.gov ID
- NCT02118805
- Acronym / sponsor ID
- QUESST / 2013P000204
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Myasthenia Gravis, Myopathies, Stroke, Parkinson's Disease
- Keywords
- ALS, Myasthenia Gravis, Myopathy, Stroke, Parkinson's Disease, Bulbar, Orofacial, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patients with ALS | – | –No intervention is used in this study. The health of muscle is monitored over time. |
| Patients with Myasthenia Gravis | – | –No intervention is used in this study. The health of muscle is monitored over time. |
| Patients with Muscle Disease | – | –No intervention is used in this study. The health of muscle is monitored over time. |
| Patients with Stroke | – | –No intervention is used in this study. The health of muscle is monitored over time. |
| Patients with Parkinson's Disease | – | –No intervention is used in this study. The health of muscle is monitored over time. |
| Healthy Volunteers | – | –No intervention is used in this study. The health of muscle is monitored over time. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited principally from the BIDMC outpatient clinics and inpatient ward service. Healthy volunteers will be recruited through online advertising.
Key inclusion criteria (2 listed)
- Established, or clinically probable, neurologic diagnosis with at least the potential for associated bulbar dysfunction
- Age 20-90 years
Key exclusion criteria (2 listed)
- History or presence of a medical condition that substantially impacts bulbar function
- Age under 20 or over 90 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seward Rutkove, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis (ALS) and Myasthenia Gravis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.