Phase
Condition
Amyotrophic Lateral Sclerosis (Als)
Myasthenia Gravis (Chronic Weakness)
Treatment
Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone
SIT Scoring
Modified Barium Swallow Study (MBSS)
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients
At least 18 years of age
Possess a diagnosis of ALS (definite, probable, probable laboratory-supported, orpossible 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 reductionof at least 1 point on either the speech or swallowing components of the ALSFRS-R inthe 6 months prior to enrollment. If 6 months of data is not available, an estimateof 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 UnitedStates. 3.4. Hearing within normal limits, as defined by self report.
Exclusion
Exclusion Criteria:
Patients
Possess a co-existing neurological or psychiatric illness that, in the opinion ofthe study team, exclude the subject from participation
Demonstrate clinically significant dementia, as determined by the ALS studyneurologist
Possess abnormal speech or swallowing processes due to a condition independent oftheir ALS diagnosis
Listeners
Have an identified speech, language, learning, or neurological disorders perself-report
Experience communicating with people with motor speech disorders
Study Design
Study Description
Connect with a study center
Hershey Medical Center ALS Clinic
Hershey, Pennsylvania 17033
United StatesSite Not Available
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