Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Speech Analysis in ALS Patients With and Without Cognitive Abnormalities: Evaluation of Sensitivity and Disease Progression
Verified date | March 2023 |
Source | Barrow Neurological Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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. Every three months, patients will undergo a series of cognitive and basic clinical outcomes tests. In addition, participants will take home a study-provided tablet on which they will complete weekly speech recording activities.
Status | Completed |
Enrollment | 26 |
Est. completion date | April 30, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: 1. male or female, age 21 or older, 2. diagnosed with definite, probable, or possible ALS according to the modified El Escorial Criteria, 3. a score of 2 or greater on the speech question of the ALSFRS-R (i.e. speech is intelligible with occasional repetition), 4. continuous internet access at home, 5. willingness and medical ability to comply with scheduled visits and study procedures, 6. 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, 7. geographic accessibility to study site, 8. for the 25 participants in Group 1, NO noted symptoms of frontotemporal cognitive dysfunction, and 9. for the 25 participants in Group 2, MUST have cognitive symptoms as noted either by themselves or a caregiver. Exclusion Criteria: 1. 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 2. any other reasons that, in the opinion of the PI, cause the candidate to be deemed unsuitable for entry into the study. |
Country | Name | City | State |
---|---|---|---|
United States | Barrow Neurological Institute | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Barrow Neurological Institute | Arizona State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in ability on Speech and Language Battery | Speech recordings made at home via a tablet using the " SpeechAssess" app. | Weekly recordings for one year | |
Secondary | Change in Montreal Cognitive Assessment | Cognitive screening tool | Administered every three months for a year | |
Secondary | Change in ALS Cognitive Behavioral Screen | Cognitive screening tool | Administered every three months for a year | |
Secondary | Change in Vital Capacity | Measure of breathing function | Administered every three months for a year | |
Secondary | Change in Negative Inspiratory Force | Measure of nasal inhale capabilities | Administered every three months for a year | |
Secondary | Change in "ALS Functional Rating Scale- Revised" | Questionnaire regarding daily functioning. Scale is measured from 0 to 48 points, with 48 being normal function and 0 indicating no functional abilities. | Administered every three months for a year |
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