Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders

NCT02118805 | Completed

• 1 other identifier: 2013P000204
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in Score on the Sydney Swallow Questionnaire (over 18 months)

  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)

  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)

  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)

  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)

  Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18

Study Arms (6)

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.

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Established, or clinically probable, neurologic diagnosis with at least the potential for associated bulbar dysfunction
• Age 20-90 years

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Myasthenia Gravis; Muscular Diseases; Stroke; Parkinson Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Neuromuscular Junction Diseases; Autoimmune Diseases; Immune System Diseases; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Seward Rutkove, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 21, 2014
• Study Start: October 1, 2013
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 16, 2024

Record last verified: 2023-04

Locations

US (1)