Speech Analysis in ALS Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03868345 |
Recruitment Status :
Recruiting
First Posted : March 11, 2019
Last Update Posted : March 11, 2019
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Condition or disease |
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ALS Amyotrophic Lateral Sclerosis Lou Gehrig Disease |
Study Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Speech Analysis in ALS Patients With and Without Cognitive Abnormalities: Evaluation of Sensitivity and Disease Progression |
Actual Study Start Date : | February 18, 2019 |
Estimated Primary Completion Date : | August 31, 2019 |
Estimated Study Completion Date : | December 31, 2019 |

- 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.
- Change in Montreal Cognitive Assessment [ Time Frame: Administered every three months for a year ]Cognitive screening tool
- Change in ALS Cognitive Behavioral Screen [ Time Frame: Administered every three months for a year ]Cognitive screening tool
- Change in Vital Capacity [ Time Frame: Administered every three months for a year ]Measure of breathing function
- Change in Negative Inspiratory Force [ Time Frame: Administered every three months for a year ]Measure of nasal inhale capabilities
- 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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868345
Contact: Kerisa Shelton, PhD | 602-406-6598 | kerisa.shelton@dignityhealth.org |
United States, Arizona | |
Barrow Neurological Institute | Recruiting |
Phoenix, Arizona, United States, 85013 | |
Contact: Jessie Duncan Jessie.Duncan@DignityHealth.org | |
Principal Investigator: Jeremy Shefner, MD | |
Principal Investigator: Shafeeq Ladha, MD |
Responsible Party: | Jeremy Shefner, Senior Vice President and Chair of Neurology, Barrow Neurological Institute |
ClinicalTrials.gov Identifier: | NCT03868345 |
Other Study ID Numbers: |
BNI-ALS-003 |
First Posted: | March 11, 2019 Key Record Dates |
Last Update Posted: | March 11, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ALS Cognitive dysfunction Speech |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases |
Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |