Amyotrophic Lateral SclerosisNCT06315673
Digital Assessment of Speech and Fine Motor Control in ALS
An observational study of Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis, Progressive Muscular Atrophy
- What is being tested?
- Digital Speech and Handwriting Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 1 Jun 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with motor neuron disease and age- and sex-matched, neurologically-healthy controls.
Who may be able to join
- [Patient Group Only] Diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria [Brooks2000], primary lateral sclerosis (PLS), or progressive muscular atrophy (PMA).
- [Patient Group Only] at least minimal speech or handwriting ability
- ALSFRS-R speech score of 2 ("intelligible speech with repeating") or greater, OR
- ALSFRS-R handwriting score of 2 ("not all words are legible") or greater.
- [Control Group Only] Possess no neurological or orthopedic problems that affects their speech or handwriting AND age-matched to the existing patient cohort.
- 18 years of age or older;
- Fluent in written and spoken English.
Who cannot join
- Currently or previously enrolled in STUDY00013892 (NCT05271435)
- Neurological or orthopedic problems (independent of their inclusionary diagnosis for the patient group) that affects their speech or handwriting
- Pregnant or nursing woman
- Prisoner or institutionalized individuals
- Have any clinically relevant medical history of other disease or diseases that, in the opinion of the research team, exclude the subject from participation (including severe cognitive dysfunction).
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the 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.
- Being tested
- Digital Speech and Handwriting Assessment
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Speech and Handwriting AssessmentBehavioural
Subjects may complete all or some of these tests, depending on functional ability.
- Handwriting battery
- Pattern tracing battery
- Speech Assessment Battery
| Study group | Role | What they receive |
|---|---|---|
| Patient | Individuals with diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria [2], primary lateral sclerosis (PLS), or progressive muscular atrophy (PMA). Receives: Behavioral: Digital Speech and Handwriting Assessment | |
| Control | Individuals with no neurological or orthopedic problems that affects their speech or handwriting AND age-matched to the existing patient cohort. Receives: Behavioral: Digital Speech and Handwriting Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speaking rate during a standardized passage
Speaking rate, in words per minute, will be determined from an audio recording of a standardized reading passage.
Measured: baseline
Residual on spiral tracing task
Handwriting tasks include tracing of a spiral. The average residual, or deviation from the target spiral (in pixels), will be determined from the handwriting file associated with the tracing task.
Measured: baseline
Secondary outcomes (4)
ALS Functional Rating Scale- Revised (ALSFRS-R)
The ALSFRS-R measures 12 aspects of physical function, ranging from one's ability to swallow and use utensils to climbing stairs and breathing. Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0.
Measured: baseline
Forced vital capacity (FVC)
FVC is collected at clinical appointments by a respiratory therapist. FVC is the volume of air that is forcefully expelled into a spirometer. FVC is expressed as a percentage (%) of predicted volume against an age, height, and ethnicity matched standard. The best result of three trials is used.
Measured: baseline
Upper motor neuron function
Reflex testing is performed by the attending neurologist at clinical appointments. Bilateral biceps, triceps, and brachioradialis reflexes will be documented according to Modified Ashworth Scale grade 0 (no tone increase) to 4 (limb rigid). Total score for bilateral muscle groups ranges from 0 to 24.
Measured: baseline
Strength testing
Strength testing is performed by the attending neurologist at clinical appointments. Bilateral deltoids, biceps, triceps, wrist extension, and interossei strength will be documented according to Medical Research Council (MRC) grade 0 (no power) to 5 (normal power). Total score for bilateral muscle groups ranges from 0 to 50.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Jul 2024
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- BioSensics
- Responsible party
- Principal investigator, Andrew Geronimo, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315673
- Sponsor's protocol ID
- STUDY00024562
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data without identifiers may be shared with other researchers at reasonable request of the PI
Publications
Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, Nakanishi A. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999 Oct 31;169(1-2):13-21. doi: 10.1016/s0022-510x(99)00210-5.
PubMed 10540002Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.
PubMed 11464847
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Assessment of Speech and Fine Motor Control in ALS
- ClinicalTrials.gov ID
- NCT06315673
- Acronym / sponsor ID
- STUDY00024562
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- BioSensics
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 18 Mar 2024 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Behavioral: Digital Speech and Handwriting AssessmentIndividuals with diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria [2], primary lateral sclerosis (PLS), or progressive muscular atrophy (PMA). |
| Control | – | Behavioral: Digital Speech and Handwriting AssessmentIndividuals with no neurological or orthopedic problems that affects their speech or handwriting AND age-matched to the existing patient cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with motor neuron disease and age- and sex-matched, neurologically-healthy controls.
Key inclusion criteria (7 listed)
- [Patient Group Only] Diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria [Brooks2000], primary lateral sclerosis (PLS), or progressive muscular atrophy (PMA).
- [Patient Group Only] at least minimal speech or handwriting ability
- [Control Group Only] Possess no neurological or orthopedic problems that affects their speech or handwriting AND age-matched to the existing patient cohort.
- 18 years of age or older;
- Fluent in written and spoken English.
Key exclusion criteria (5 listed)
- Currently or previously enrolled in STUDY00013892 (NCT05271435)
- Neurological or orthopedic problems (independent of their inclusionary diagnosis for the patient group) that affects their speech or handwriting
- Pregnant or nursing woman
- Prisoner or institutionalized individuals
- Have any clinically relevant medical history of other disease or diseases that, in the opinion of the research team, exclude the subject from participation (including severe cognitive dysfunction).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Speech and Handwriting AssessmentSubjects may complete all or some of these tests, depending on functional ability. * Handwriting battery * Pattern tracing battery * Speech Assessment Battery | Behavioural | Control, Patient |
Primary outcome
Speaking rate during a standardized passage
Time frame: baseline
Speaking rate, in words per minute, will be determined from an audio recording of a standardized reading passage.
Residual on spiral tracing task
Time frame: baseline
Handwriting tasks include tracing of a spiral. The average residual, or deviation from the target spiral (in pixels), will be determined from the handwriting file associated with the tracing task.
4 secondary outcomes
ALS Functional Rating Scale- Revised (ALSFRS-R)
Time frame: baseline
Forced vital capacity (FVC)
Time frame: baseline
Upper motor neuron function
Time frame: baseline
Strength testing
Time frame: baseline
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 29 Jun 2026.
- Background: PubMed 10540002Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, Nakanishi A. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999 Oct 31;169(1-2):13-21. doi: 10.1016/s0022-510x(99)00210-5.
- Background: PubMed 11464847Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.
- Individual participant dataSharing planned: Yes. Study data without identifiers may be shared with other researchers at reasonable request of the PI
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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 Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis, run by Milton S. Hershey Medical Center 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 7 inclusion and 5 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 29 Jun 2026. 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?
Speaking rate during a standardized passage (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06315673, which also lists 2 linked publications.
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 29 Jun 2026.