Stroke Clinical Trial
— QUESSTOfficial title:
Quantitative Ultrasonography and Electrical Impedance Myography: Speech and Swallowing Technologies for Use in Neurological Disorders
NCT number | NCT02118805 |
Other study ID # | 2013P000204 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | December 31, 2021 |
Verified date | April 2023 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 | |
Secondary | Change in Score on the Sydney Swallow Questionnaire (over 18 months) | Participants with neurological conditions will answer questions about swallowing | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 | |
Secondary | 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 | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 | |
Secondary | 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 | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 | |
Secondary | 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 | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 | |
Secondary | 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 | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 | |
Secondary | 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 | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 | |
Secondary | 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 | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 | |
Secondary | 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 | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18 |
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