Home Telemonitoring of Bulbar Function by Acoustic Measurement of Swallowing and Speech Sounds in ALS

Study Purpose:

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.

Study Status:



Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:


Intervention Name:






Study Chair(s)/Principal Investigator(s):

Andrew Geronimo, PhD, Penn State College of Medicine

Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

Andrew Geronimo, PhD / email hidden; JavaScript is required / 717-531-0003

Full Study Summary:

Most individuals with ALS experience bulbar function deterioration over the course of the disease which impacts their quality of life significantly. Furthermore, in some patients, bulbar symptoms are an initial presenting symptom of ALS. Identifying these changes, which may be rapid in some individuals, is complicated by the recent acceleration of virtual care delivery.

The investigators propose a longitudinal home study of ALS patients to assess bulbar progression via a smartphone-based, self-administered remote speech and swallow assessment (rSSA). The overall hypothesis is that this monitoring protocol can be used in a way that, 1) is satisfactory to the patient, 2) performs at least as well as standard clinical measures of dysarthria and dysphagia, and 3) resolves the development of emergence of speech and swallowing pathologies in ALS.

Study Sponsor:

Milton S. Hershey Medical Center

Estimated Enrollment:


Estimated Study Start Date:

01 / 01 / 2022

Estimated Study Completion Date:

09 / 01 / 2023

Posting Last Modified Date:

03 / 02 / 2023

Date Study Added to neals.org:

05 / 17 / 2021

Minimum Age:

18 Years

Maximum Age:


Inclusion Criteria:


1. At least 18 years of age

2. Possess a diagnosis of ALS (definite, probable, probable laboratory-supported, or possible by El Escorial criteria [35])

3. Have symptom onset within the last 3 years

4. 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

5. 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.

6. Have a life expectancy ≥ 6 months as determined by the attending neurologist

7. Be fluent in written and spoken English

8. Possess a smartphone capable of running the study application

9. Follow up in the Penn State Hershey multidisciplinary ALS clinic over next 6 months

10. Be able to visit the study site for in-person procedures at weeks 0 and 24


1. Between 18 and 40 years of age

2. Native speakers of American English 2.3. Currently residing within the United States. 3.4. Hearing within normal limits, as defined by self report.

Exclusion Criteria:


1. Possess a co-existing neurological or psychiatric illness that, in the opinion of the study team, exclude the subject from participation

2. Demonstrate clinically significant dementia, as determined by the ALS study neurologist

3. Possess abnormal speech or swallowing processes due to a condition independent of their ALS diagnosis


1. Have an identified speech, language, learning, or neurological disorders per self-report

2. Experience communicating with people with motor speech disorders

Hershey Medical Center ALS Clinic | Recruiting

Andrew Geronimo, PhD / 717-531-0003 Ext. 282576 / email hidden; JavaScript is required

Hershey, Pennsylvania 17033
United States