Digital Assessment of Speech and Fine Motor Control in ALS
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ClinicalTrials.gov Identifier: NCT06315673 |
Recruitment Status :
Not yet recruiting
First Posted : March 18, 2024
Last Update Posted : May 9, 2024
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Tracking Information | |||||||||||||
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First Submitted Date | March 12, 2024 | ||||||||||||
First Posted Date | March 18, 2024 | ||||||||||||
Last Update Posted Date | May 9, 2024 | ||||||||||||
Estimated Study Start Date | June 1, 2024 | ||||||||||||
Estimated Primary Completion Date | March 30, 2026 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title | Digital Assessment of Speech and Fine Motor Control in ALS | ||||||||||||
Official Title | Digital Assessment of Speech and Fine Motor Control in ALS | ||||||||||||
Brief Summary | This is a single-session, case-control study that incorporates digital tools for assessing speech and motor function in motor neuron disease. Patients with motor neuron disease (including amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA)) and age-matched healthy controls will be enrolled. Subjects will complete a speech and handwriting assessment during the study visit on a tablet computer (BioSensics LLC, Newton, MA). We will explore whether these digital biomarkers are sensitive to functional disease severity as reported by the ALS Functional Rating Scale - Revised (ALFRS-R) [1]. We will also compare assessment data between the patient and control groups. | ||||||||||||
Detailed Description | ALS is a progressive neuromuscular disease that causes weakness and inevitably affecting multiple motor processes within the body. To assess changes in functional mobility, clinicians and clinical investigators often rely on the ALS Functional Rating Scale - Revised (ALSFRS-R), a standardized 12-item questionnaire that has been in use for decades. Although thoroughly validated, this scale has received criticism for providing a coarse reflection of a patient's disease, scaling non-linearly within and across functional domains, and without the sensitivity to reflect day-to-day variability or small but meaningful changes. This study includes collection of digital speech and fine motor control assessment data at a single study visit. Features extracted from this data will be compared with standard clinical disease outcome measures and also the features derived from control participant data. We will use these comparisons to explore the use of these digital assessments in capturing the range of functional changes that occur in ALS and the related motor neuron diseases of PLS and PMA that are regularly treated in the ALS clinic. |
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Study Type | Observational | ||||||||||||
Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||||||||||
Biospecimen | Not Provided | ||||||||||||
Sampling Method | Non-Probability Sample | ||||||||||||
Study Population | Patients with motor neuron disease and age- and sex-matched, neurologically-healthy controls. | ||||||||||||
Condition |
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Intervention | Behavioral: Digital Speech and Handwriting Assessment
Subjects may complete all or some of these tests, depending on functional ability.
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status | Not yet recruiting | ||||||||||||
Estimated Enrollment |
50 | ||||||||||||
Original Estimated Enrollment | Same as current | ||||||||||||
Estimated Study Completion Date | March 30, 2027 | ||||||||||||
Estimated Primary Completion Date | March 30, 2026 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers | Yes | ||||||||||||
Contacts |
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Listed Location Countries | Not Provided | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number | NCT06315673 | ||||||||||||
Other Study ID Numbers | STUDY00024562 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Andrew Geronimo, Milton S. Hershey Medical Center | ||||||||||||
Original Responsible Party | Same as current | ||||||||||||
Current Study Sponsor | Milton S. Hershey Medical Center | ||||||||||||
Original Study Sponsor | Same as current | ||||||||||||
Collaborators | BioSensics | ||||||||||||
Investigators | Not Provided | ||||||||||||
PRS Account | Milton S. Hershey Medical Center | ||||||||||||
Verification Date | May 2024 |