DESIPHER_Speech Degradation as an Indicator of Physiological Degeneration in ALS

NCT02675075 | Completed Results

• 2 other identifiers: N1902-PI21RX001902
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

A disease called Amyotrophic lateral sclerosis (or ALS), which leads to difficulty swallowing, breathing, and movement, has been found to be higher for those serving in the military than in the general population. There are approximately 4,200 Veterans with ALS and roughly 1,000 new cases each year. When doctors attempt to determine the degree to which an ALS patient is suffering from the disease, they apply tests that are "graded" by experts. However, this approach to testing patients may not be very accurate. Researchers aim to use a system called DESIPHER to "listen" to ALS patients and find speech mistakes related to their condition. Researchers believe that, by detecting different types of errors, DESIPHER serves as a new kind of indicator of medical problems such as difficulty breathing or swallowing, without human "grading". This may also lead to a better system for automatically understanding ALS patients' speech.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis; Voice; Voice Quality; Total Lung Capacity

Outcome Measures

Primary Outcomes (1)

• Change in Percent of Expected Lung Force Vital Capacity

  Forced Vital Capacity (FVC) measures the ability of the lung to move air. The change in FVC was calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followup.

  Baseline, and every 3 months up to 24 months

Secondary Outcomes (2)

• Change in Tongue Strength

  Baseline, 3 Month intervals up to 24 months, calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followup

• Change in Speech - as Measured by Speech Divergence

  Baseline, 3 Month intervals up to 24 months, calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followup

Study Arms (1)

Veterans With ALS

This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A Cohort of Veteran diagnosed with ALS seen at the Tampa VA

You may qualify if:

• Veterans will be diagnosed with ALS
• Native speakers of U.S. English
• Will have bulbar involvement identified during initial ALS inpatient evaluation
• Forced vital capacity (FVC) of greater than 50% of the expected value for age
• An Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) Score of 40 or greater

You may not qualify if:

• A diagnosis of dementia
• FVC less than 50%
• Inability to speak
• Or inability to follow directions

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Florida Institute for Human and Machine Cognition: collaborator

Study Sites (1)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

This study relied on the clinical team records to capture several variables. While there was clear protocols in place for clinicians, The ALSFRS-R and Speech Intelligibility Index both had missing data in the clinical record limiting analysis.

Results Point of Contact

• Title: Dr. Sam Phillips
• Organization: James A. Haley VA Hospital

samuel.phillips@va.gov

813 558 3995

Study Officials

• Samuel L. Phillips, PhD

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: February 5, 2016
• Study Start: January 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 18, 2020
• Results First Posted: August 7, 2020

Record last verified: 2020-08

Locations

US (1)