Status:
ACTIVE_NOT_RECRUITING
Remote Speech and Swallowing Assessment in ALS
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Penn State University
Congressionally Directed Medical Research Programs
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Brief 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 (r...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04889898
Start Date
January 1 2022
End Date
September 1 2026
Last Update
October 8 2025
Active Locations (1)
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1
Hershey Medical Center ALS Clinic
Hershey, Pennsylvania, United States, 17033