Remote Speech and Swallowing Assessment in ALS

Last updated: October 2, 2024
Sponsor: Milton S. Hershey Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

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

NCT04889898
STUDY00016872
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients

  1. At least 18 years of age

  2. Possess a diagnosis of ALS (definite, probable, probable laboratory-supported, orpossible 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 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.

  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 UnitedStates. 3.4. Hearing within normal limits, as defined by self report.

Exclusion

Exclusion Criteria:

Patients

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

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

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

Listeners

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

  2. Experience communicating with people with motor speech disorders

Study Design

Total Participants: 170
Treatment Group(s): 4
Primary Treatment: Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone
Phase:
Study Start date:
January 01, 2022
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Hershey Medical Center ALS Clinic

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

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