ALSNCT03868345
Speech Analysis in ALS Patients
An observational study of ALS and Amyotrophic Lateral Sclerosis, run by Barrow Neurological Institute at 1 site in United States.
Trial 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. Every three months, patients will undergo a series of cognitive and basic clinical outcomes tests. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- ALS, Amyotrophic Lateral Sclerosis, Lou Gehrig Disease
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2019to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ALS, diagnosed as definite, probable, or possible ALS according to the modified El Escorial Criteria.
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Barrow Neurological Institute
Phoenix, Arizona, 85013
About this study
Official title: 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.
Read the 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.
- Conditions
- ALS, Amyotrophic Lateral Sclerosis, Lou Gehrig Disease
- Keywords
- ALS, Cognitive dysfunction, Speech
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Cognitive Dysfunction, Speech
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ability on Speech and Language Battery
Speech recordings made at home via a tablet using the " SpeechAssess" app.
Measured: Weekly recordings for one year
Secondary outcomes (5)
Change in Montreal Cognitive Assessment
Cognitive screening tool
Measured: Administered every three months for a year
Change in ALS Cognitive Behavioral Screen
Cognitive screening tool
Measured: Administered every three months for a year
Change in Vital Capacity
Measure of breathing function
Measured: Administered every three months for a year
Change in Negative Inspiratory Force
Measure of nasal inhale capabilities
Measured: Administered every three months for a year
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.
Measured: Administered every three months for a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start18 Feb 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barrow Neurological Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Jeremy Shefner, Barrow Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868345
- Sponsor's protocol ID
- BNI-ALS-003
- Status last verified
- Mar 2023
- First submitted
- 6 Feb 2019
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Analysis in ALS Patients With and Without Cognitive Abnormalities: Evaluation of Sensitivity and Disease Progression
- ClinicalTrials.gov ID
- NCT03868345
- Acronym / sponsor ID
- BNI-ALS-003
- Conditions
- ALS, Amyotrophic Lateral Sclerosis, Lou Gehrig Disease
- Keywords
- ALS, Cognitive dysfunction, Speech
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Barrow Neurological InstituteUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ALS, diagnosed as definite, probable, or possible ALS according to the modified El Escorial Criteria.
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Change in Montreal Cognitive Assessment
Time frame: Administered every three months for a year
Change in ALS Cognitive Behavioral Screen
Time frame: Administered every three months for a year
Change in Vital Capacity
Time frame: Administered every three months for a year
Change in Negative Inspiratory Force
Time frame: Administered every three months for a year
Change in "ALS Functional Rating Scale- Revised"
Time frame: Administered every three months for a year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS and Amyotrophic Lateral Sclerosis, run by Barrow Neurological Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ability on Speech and Language Battery (time frame: Weekly recordings for one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.