Remote Speech and Swallowing Assessment in ALS

Completed

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT04889898

Run by

Milton S. Hershey Medical Center

People needed

200

Starts

2022-01-01

Expected to finish

2026-06-25

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients
• 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
• Follow up in the Penn State Hershey multidisciplinary ALS clinic over next 6 months
• Be able to visit the study site for in-person procedures at weeks 0 and 24
• Listeners
• Between 18 and 40 years of age
• Native speakers of American English 2.3. Currently residing within the United States. 3.4. Hearing within normal limits, as defined by self report.

You may not qualify if…

• Patients
• 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
• Listeners
• Have an identified speech, language, learning, or neurological disorders per self-report
• Experience communicating with people with motor speech disorders

Where it is running

• Hershey Medical Center ALS Clinic — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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