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Remote Speech and Swallowing Assessment in ALS

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ClinicalTrials.gov Identifier: NCT04889898
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : February 22, 2022
Sponsor:
Collaborators:
Penn State University
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
Andrew Geronimo, Milton S. Hershey Medical Center

Study Description
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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 (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.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Device: Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone Radiation: Modified Barium Swallow Study (MBSS) Behavioral: Speech Intelligibility Test (SIT) Behavioral: SIT Scoring

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 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 Design
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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Home Telemonitoring of Bulbar Function by Acoustic Measurement of Swallowing and Speech Sounds in ALS
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
ALS Patients
All ALS patients will be enrolled in this arm, which involves a combination of clinical and home-based assessments of speech and swallowing.
 Device: Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone
[Patients only] Weekly completion of audio recordings of speech and swallowing performed at home by the subject using the study smartphone application on their personal device.

Radiation: Modified Barium Swallow Study (MBSS)
[Patients only] MBSS is an instrumented evaluation of oropharyngeal swallowing function that is performed using videofluoroscopy.
Other Name: Videofluoroscopic Swallowing Study (VFSS)

Behavioral: Speech Intelligibility Test (SIT)
[Patients only] The SIT is a standardized test for measuring speech intelligibility.
Listeners
Healthy listeners will be recruited to listen to the audio recordings of patients in the study in order to judge the intelligibility of their speech.
 Behavioral: SIT Scoring
[Listeners only] Listeners will judge the intelligibility of speech recordings made by patients in the study.


Outcome Measures
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Primary Outcome Measures :
  1. Digital recording of speech and swallow [ Time Frame: weekly for 24 weeks ]
    Audio recordings of speech tasks and spontaneous swallowing task


Secondary Outcome Measures :
  1. MBS Impairment Profile (MBSImp) [ Time Frame: Weeks 0 and 24 ]
    Standardized scoring for the MBSS in 17 domains. Domains are aggregated in to scores for Oral Impairment (0-22), Pharyngeal Impairment (0-29), and Esophageal Impairment (0-4), with higher scores indicating impaired function.

  2. Speech Intelligibility Task (SIT) Intelligibility listener scoring [ Time Frame: Weeks 0, 12, and 24 ]
    Listeners will score the intelligibility of patient SIT recordings

  3. ALS Functional Rating Scale - Revised (ALSFRS-R) [ Time Frame: Weeks 0, 12, and 24 ]
    ALS Specific Assessment of physical function ranging from 0-48, with 48 being normal function.

  4. Center for Neurological Study - Bulbar Function Scale (CNS-BFS) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ]
    Self-administered rating scale for speech (7-49) and salivation (7-35) functions, with high scores indicating impaired function.

  5. Mann Assessment of Swallowing Ability (MASA) [ Time Frame: Weeks 0, 12, and 24 ]
    A standard clinical swallowing assessment performed by the speech-language pathologist. Scores range from 38-200, with lower scores indicating higher impairment.

  6. EAT-10 Questionnaire [ Time Frame: Weeks 0, 12, and 24 ]
    A self-reported assessment of eating and swallowing function. Scores range from 0-40, with higher scores indicating higher impairment.

  7. Forced Vital Capacity (FVC) [ Time Frame: Weeks 0, 12, and 24 ]
    A standard clinical respiratory assessment of vital capacity

  8. Maximal Inspiratory Pressure (MIP) [ Time Frame: Weeks 0, 12, and 24 ]
    A standard clinical respiratory assessment of inspiratory strength


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Population 1: Patients with ALS Population 2: Healthy Listeners
Criteria

Inclusion Criteria:

Patients

  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

Listeners

  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:

Patients

  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

Listeners

  1. Have an identified speech, language, learning, or neurological disorders per self-report
  2. Experience communicating with people with motor speech disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04889898


Contacts
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Contact: Andrew Geronimo, PhD 717-531-0003 ext 282576 ageronimo@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Hershey Medical Center ALS Clinic Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Andrew Geronimo, PhD    717-531-0003 ext 282576    ageronimo@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Penn State University
Congressionally Directed Medical Research Programs
Investigators
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Principal Investigator: Andrew Geronimo, PhD Penn State College of Medicine
More Information
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Responsible Party: Andrew Geronimo, Assistant Professor, Neurosurgery, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04889898    
Other Study ID Numbers: STUDY00016872
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: February 22, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew Geronimo, Milton S. Hershey Medical Center:
telemonitoring
digital health
mobile health
dysphagia
dysarthria
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases