Delineating Swallowing Impairment and Decline in ALS

• Register: ClinicalTrials.gov
• Last refreshed on: 6 March 2023
• Main ID: NCT02962050
• Date of registration: 04/11/2016
• Prospective Registration: Yes
• Primary sponsor: University of Florida
• Public title: Delineating Swallowing Impairment and Decline in ALS
• Scientific title: Delineating Physiologic Mechanisms of Swallowing Impairment and Decline in ALS
• Date of first enrolment: May 31, 2017
• Target sample size: 109
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02962050
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Emily Plowman, PhD
• Affiliation: University of Florida

Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnosis of probable or definite ALS

Exclusion Criteria:

- allergies to barium or capsaicin

- History of stroke

- Head and Neck Cancer

- Other disorder that might contribute to swallowing impairment

- Not enrolled in other research investigations that might impact swallowing

- Not pregnant



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: Capsaicin Challenge

Device: Pulmonary Function Testing

Device: Voluntary Peak Cough Flow Testing

Device: Iowa Oral Performance Instrument

Procedure: Videofluoroscopic Swallowing Study (VFSS)

Other: Eating Assessment Tool 10

Other: The Center for Neurologic Study Bulbar Function Scale

Primary Outcome(s)

Global Swallowing Function [Time Frame: Baseline, every 3 months through study completion, an average of 2 years.]

Secondary ID(s)

R01NS100859

IRB201602098-N

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurological Disorders and Stroke (NINDS)