- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03868345
Speech Analysis in ALS Patients
March 7, 2023 updated by: Jeremy Shefner, Barrow Neurological Institute
Speech Analysis in ALS Patients With and Without Cognitive Abnormalities: Evaluation of Sensitivity and Disease Progression
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.
Study Overview
Status
Completed
Conditions
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 dysfunction.
Approximately 15% of patients meet formal criteria for frontotemporal dementia (FTD).
Certain genetic forms of ALS (e.g., mutations in C9orf72) have even higher incidences of FTD.
The presence of cognitive abnormalities is an adverse risk factor for survival, and its presence influences the ability of patients to cooperate in clinical trials.
However, screening for frontotemporal abnormalities is frequently not performed in ALS clinics, and tools for diagnosing cognitive dysfunction are either time consuming or insensitive.
Additionally, the frequently co-existing dysarthria complicates the assessment and may mask more subtle cognitive deficits.
Once identified, ways of following progressive decline are also lacking.
In an ongoing study, it has been shown that a sophisticated suite of speech and language analytics, developed by two of the investigators, can identify abnormalities in cognitively normal ALS patients without speech symptoms, and predict important functional changes outside of the speech domain.
In this study, investigators will evaluate both speech and language in 50 patients with ALS both with and without symptoms of cognitive decline.
This evaluation will be paired with two cognitive screening tools frequently used in ALS clinics, the ALS Cognitive Behavioral Screen (ALS-CBS) and the Montreal Cognitive Assessment (MoCA).
The investigators will evaluate the extent to which speech and language deficits precede abnormalities as measured by the above tools and determine whether cognitive change can be accurately followed over 12 months using speech and language measures.
It is hypothesized that speech and language measures will accurately and sensitively predict cognitive changes.
If so, such measures may be very useful in future studies of potential therapeutic agents for ALS-FTD and other dementias.
Study Type
Observational
Enrollment (Actual)
26
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kerisa Shelton, PhD
- Phone Number: 602-406-6598
- Email: kerisa.shelton@dignityhealth.org
Study Locations
-
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Arizona
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Phoenix, Arizona, United States, 85013
- Barrow Neurological Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with ALS, diagnosed as definite, probable, or possible ALS according to the modified El Escorial Criteria.
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ability on Speech and Language Battery
Time Frame: Weekly recordings for one year
|
Speech recordings made at home via a tablet using the " SpeechAssess" app.
|
Weekly recordings for one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Montreal Cognitive Assessment
Time Frame: Administered every three months for a year
|
Cognitive screening tool
|
Administered every three months for a year
|
Change in ALS Cognitive Behavioral Screen
Time Frame: Administered every three months for a year
|
Cognitive screening tool
|
Administered every three months for a year
|
Change in Vital Capacity
Time Frame: Administered every three months for a year
|
Measure of breathing function
|
Administered every three months for a year
|
Change in Negative Inspiratory Force
Time Frame: Administered every three months for a year
|
Measure of nasal inhale capabilities
|
Administered every three months for a year
|
Change in "ALS Functional Rating Scale- Revised"
Time Frame: Administered every three months for a year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 18, 2019
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
February 6, 2019
First Submitted That Met QC Criteria
March 6, 2019
First Posted (Actual)
March 11, 2019
Study Record Updates
Last Update Posted (Estimate)
March 9, 2023
Last Update Submitted That Met QC Criteria
March 7, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BNI-ALS-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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