Remote Speech and Swallowing Assessment in ALS (NCT04889898) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Remote Speech and Swallowing Assessment in ALS
United States170 participantsStarted 2022-01-01
Plain-language summary
The investigators propose a longitudinal home study of ALS patients to measure the severity of speech and swallowing (bulbar) impairment via a smartphone-based, remote speech and swallow assessment (rSSA). The study is designed to assess the feasibility and validity of such a monitoring intervention. Furthermore, it is proposed that regular monitoring of these two bulbar processes may shed light on their co-evolution over the course of ALS.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 18 years of age
✓. Possess a diagnosis of ALS (definite, probable, probable laboratory-supported, or possible by El Escorial criteria \[35\])
✓. Have symptom onset within the last 3 years
✓. Demonstrate a score of 2 or 3 in either the speech (item #1) or swallowing (item #3) components of the ALSFRS-R at time of enrollment
✓. Demonstrate decline in bulbar function prior to enrollment, measured by a reduction of at least 1 point on either the speech or swallowing components of the ALSFRS-R in the 6 months prior to enrollment. If 6 months of data is not available, an estimate of the change in ALSFRS-R will be calculated from the time of symptom onset.
✓. Have a life expectancy ≥ 6 months as determined by the attending neurologist
✓. Be fluent in written and spoken English
✓. Possess a smartphone capable of running the study application
Exclusion criteria
✕. Possess a co-existing neurological or psychiatric illness that, in the opinion of the study team, exclude the subject from participation
✕. Demonstrate clinically significant dementia, as determined by the ALS study neurologist
✕. Possess abnormal speech or swallowing processes due to a condition independent of their ALS diagnosis