Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-01 @ 10:50 PM
Study NCT ID:
NCT02118805
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2014-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D009157', 'term': 'Myasthenia Gravis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-13', 'studyFirstSubmitDate': '2014-04-08', 'studyFirstSubmitQcDate': '2014-04-17', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Muscle Health over 18 months by Standard Ultrasound', 'timeFrame': 'Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Change in Score on the Sydney Swallow Questionnaire (over 18 months)', 'timeFrame': 'Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18', 'description': 'Participants with neurological conditions will answer questions about swallowing'}, {'measure': 'Change in Number of Seconds It takes to Repeat Individual Words Ten Times (over 18 months)', 'timeFrame': 'Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18', 'description': 'Participants with neurological conditions will be asked to repeat "pepper" and "ticker" ten times as quickly as possible'}, {'measure': 'Change in Number of Seconds It Takes to Swallow of 3 ounces of Water (over 18 months)', 'timeFrame': 'Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18', 'description': 'Participants with neurological conditions will be asked to perform this task if safe'}, {'measure': 'Change in Score on the Amyotrophic Lateral Sclerosis Rating Scale - Revised (ALSFRS-R) (over 18 months)', 'timeFrame': 'Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18', 'description': 'Participants who have been diagnosed with ALS will answer questions about function, including speech and swallowing'}, {'measure': 'Change in Score on the Quantitative Myasthenia Gravis Scale (over 18 months)', 'timeFrame': 'Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18', 'description': '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'}, {'measure': "Change in Score on the United Parkinson's Disease Rating Scale (UPDRS) (over 18 months)", 'timeFrame': 'Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18', 'description': "Participants who have been diagnosed with Parkinson's Disease will be asked questions about function, including speech and swallowing"}, {'measure': 'Change in Muscle Health by Standard Concentric Needle Electromyography (EMG) (over 18 months)', 'timeFrame': 'Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18', 'description': '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'}, {'measure': 'Change in Muscle Health by Specialized Electrical Impedance Arrays', 'timeFrame': 'Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ALS', 'Myasthenia Gravis', 'Myopathy', 'Stroke', "Parkinson's Disease", 'Bulbar', 'Orofacial', 'Ultrasound', 'Electrical Impedance Myography'], 'conditions': ['Amyotrophic Lateral Sclerosis (ALS)', 'Myasthenia Gravis', 'Myopathies', 'Stroke', "Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.\n\nWhen 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited principally from the BIDMC outpatient clinics and inpatient ward service. Healthy volunteers will be recruited through online advertising.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established, or clinically probable, neurologic diagnosis with at least the potential for associated bulbar dysfunction\n* Age 20-90 years\n\nExclusion Criteria:\n\n* History or presence of a medical condition that substantially impacts bulbar function\n* Age under 20 or over 90 years'}, 'identificationModule': {'nctId': 'NCT02118805', 'acronym': 'QUESST', 'briefTitle': 'Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Quantitative Ultrasonography and Electrical Impedance Myography: Speech and Swallowing Technologies for Use in Neurological Disorders', 'orgStudyIdInfo': {'id': '2013P000204'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with ALS', 'description': 'No intervention is used in this study. The health of muscle is monitored over time.'}, {'label': 'Patients with Myasthenia Gravis', 'description': 'No intervention is used in this study. The health of muscle is monitored over time.'}, {'label': 'Patients with Muscle Disease', 'description': 'No intervention is used in this study. The health of muscle is monitored over time.'}, {'label': 'Patients with Stroke', 'description': 'No intervention is used in this study. The health of muscle is monitored over time.'}, {'label': "Patients with Parkinson's Disease", 'description': 'No intervention is used in this study. The health of muscle is monitored over time.'}, {'label': 'Healthy Volunteers', 'description': 'No intervention is used in this study. The health of muscle is monitored over time.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Seward Rutkove, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology', 'investigatorFullName': 'Seward Rutkove', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}