Status:

COMPLETED

Speech Analysis in ALS Patients

Lead Sponsor:

Barrow Neurological Institute

Collaborating Sponsors:

Arizona State University

Conditions:

ALS

Amyotrophic Lateral Sclerosis

Eligibility:

All Genders

21+ years

Brief Summary

The purpose of this study is to find out if changes in speech can signal changes in the ability to think or remember. ALS patients with and without cognitive dysfunction will be followed for one year....

Detailed Description

Cognitive dysfunction is increasingly recognized as a core feature of amyotrophic lateral sclerosis (ALS). With appropriate testing, up to 50% of ALS patients will show evidence of frontotemporal dysf...

Eligibility Criteria

Inclusion

  • male or female, age 21 or older,
  • diagnosed with definite, probable, or possible ALS according to the modified El Escorial Criteria,
  • a score of 2 or greater on the speech question of the ALSFRS-R (i.e. speech is intelligible with occasional repetition),
  • continuous internet access at home,
  • willingness and medical ability to comply with scheduled visits and study procedures,
  • ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations,
  • geographic accessibility to study site,
  • for the 25 participants in Group 1, NO noted symptoms of frontotemporal cognitive dysfunction, and
  • for the 25 participants in Group 2, MUST have cognitive symptoms as noted either by themselves or a caregiver.

Exclusion

  • unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant's ability to comply with the protocol, and
  • any other reasons that, in the opinion of the PI, cause the candidate to be deemed unsuitable for entry into the study.

Key Trial Info

Start Date :

February 18 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 30 2021

Estimated Enrollment :

26 Patients enrolled

Trial Details

Trial ID

NCT03868345

Start Date

February 18 2019

End Date

April 30 2021

Last Update

March 9 2023

Active Locations (1)

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Barrow Neurological Institute

Phoenix, Arizona, United States, 85013