An observational study in Amyotrophic Lateral Sclerosis and Motor Neurone Disease, sponsored by University of Dublin, Trinity College. Recruiting at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by University of Dublin, Trinity College · Observational
Among 32 studies in Amyotrophic Lateral Sclerosis with a site in Ireland — 5 open to participants now, 11 under way, 4 of them phase 3. Amyotrophic Lateral Sclerosis · Ireland.
Among the 32 studies in Amyotrophic Lateral Sclerosis with a site in Ireland, this one is one of 2 that started in 2024, is one of 6 observational ones, reaches primary completion later than 8 of the 10 other live ones, and was the 29th registered.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
Browse Amyotrophic Lateral Sclerosis studies →5 of the 32 studies in Amyotrophic Lateral Sclerosis with a site in Ireland are open now. Recruiting first, the newest first:
Prilenia · Sites in Ireland, United States, Belgium and 10 more countries
Zydus Therapeutics Inc. · Sites in Ireland, United States, Australia and 9 more countries
University of Dublin, Trinity College · Sites in Ireland
University of Dublin, Trinity College · Sites in Ireland
A study can be open while its sites in Ireland have not opened yet or have stopped. Only those recruiting at a site in Ireland →
Of the 192 Amyotrophic Lateral Sclerosis studies recruiting now, 117 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 108 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.
Median enrollment 325 across the 26 interventional studies, 189 across the 6 observational. Of the 19 that completed or were terminated, 13 (68%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 32 have an industry lead sponsor. The 10 most frequent:
University of Dublin, Trinity College is the lead sponsor of 73 studies on the registry; 13 are open to participants now.
University of Dublin, Trinity College has 4 studies filed under Amyotrophic Lateral Sclerosis — fewer than ten, so there is no comparison to draw.
2 of the studies in Amyotrophic Lateral Sclerosis with a site in Ireland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05663008University of Dublin, Trinity CollegeImpairments of Neuro-muscular Communication in Motor-Neuron Disease: A Bio-Marker for Early and Personalised Diagnosis | 2027-01-30 |
| NCT06820008University of Dublin, Trinity CollegeMeasurement and Impact of Physical Impairment in Amyotrophic Lateral Sclerosis: Use of Digital Technologies - a Precision ALS Project | 2027-06-01 |
Among the 32 studies in Amyotrophic Lateral Sclerosis with a site in Ireland, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Amyotrophic Lateral Sclerosis (ALS), the most common form of Motor Neuron Disease (MND), is a neurodegenerative disease. At present there are limited treatment options for this disease which progressively affects physical function, i.e., the ability to speak, breathe, walk, and perform activities of daily living. ALS is a rare disease, and can present differently amongst individuals, therefore global collaboration is vital to have enough participants in studies to evaluate the effects of new treatments more precisely.
There are now many novel technologies that measure physical function which could be used in research studies to allow people with ALS to participate, in-part from home, knowing that they have access to the best clinical trials but with minimal time and travel burden. Their accuracy and the ability/willingness of people with ALS to use them need to be evaluated before they are accepted.
One of the traditional measurements used in research is called the ALS Functional Rating Scale -revised (ALSFRS-r) but this measurement has been criticised for being unable to pick up small changes and, in the digital age, outdated. The primary aim of this study is to develop a digital toolkit for more accurate measurement of physical aspects of ALS. It will test new technologies that measure physical function (i.e., walking, speech, swallow, strength, respiration (breathing), dexterity) that can be used by people with ALS in their own home.
This study has two aims:
Firstly, to test a selection of new digital technologies (in the form of devices, online systems and applications used on smartphones/electronic tablets) that measure physical function (e.g., walking, speech, strength) and assess whether the technologies are easy to use and acceptable both to people with ALS/MND and healthcare professionals.
Secondly, to measure how good technologies are at picking up changes in physical function over time and how they compare to older measures that are usually employed by clinicians.
This study will recruit 60 people with the ALS form of MND who attend a MND clinic in Dublin, Ireland. The study will run from November 2024 to December 2027 approximately. During this period, each participant will be asked to take part for a duration of 12 months.
The study will compare measurements of physical function collected by a researcher in the traditional way, with new ways of measuring the same functions, using technologies that can be used at home by the person with ALS. The experience of people using the technologies at home will be evaluated with interviews and questionnaires.
Over the 12-month duration, participants will be assessed in person by members of the research team on 3 occasions. These assessments will be carried out in the clinic setting or can be completed at the participant's home instead if needed.
In between the in-person assessments, participants will also do assessments in their own home every week using technologies, either independently or with telephone or video support from a researcher. The technologies that the participant use at home will be matched to the ones that were assigned to them for the in-person assessment at the beginning. Participants will use only technologies that are suited to them. The researcher will talk to participants about which technologies are suitable for them and which they are comfortable to use.
Participants coded data collected using the new technologies will be analyzed using established methods and newer methods such as artificial intelligence (AI). AI refers to the ability of computers and digital devices to learn and simulate human intelligence. Machine learning, a field within AI, analyses large data sets to develop models that improve as more data is added. Analysis of participants coded data will be for research purposes only and will not be used for their medical care.
Ultimately this study will create new knowledge on the role of technology in physical measurement in MND and how it can be successfully used in future studies to help find effective treatments.
The primary aim of this study is to investigate the validity and usability of novel digital technologies in the measurement of physical impairments (speech, swallow, strength, dexterity, mobility, and respiration) in ALS and the adherence to their use over time. The technologies that will be used in the study are as follows:
Usability will be measured by means of a questionnaire called the System Usability Scale (SUS) and a semi-structured interview with a researcher.
The objectives of the study are to:
Participants will complete regular assessments of physical function remotely ('at-home') using novel digital technologies and will in parallel complete three researcher-led ('in-person') assessments of comparable constructs. The in-person assessments will take place either in the clinical research centre, Beaumont Hospital or during an outreach home visit by a member of the research team, based on participant preference. On recruitment to the study, baseline demographic and clinical information will be collected from the participant and their Beaumont Hospital medical record. Participants will be followed up for one year. Participants will be recruited over 18 months. The anticipated total study duration is approximately 3 years, including data analysis.
In-person assessments: The researcher will administer traditional assessments (as gold standard comparison for remote measurements) and will complete assessments using novel technologies where appropriate. In-person assessments will take place at baseline, 3 months and 12 months (or at withdrawal from the study).
This assessment battery will include:
Additionally traditional validated questionnaires and rating scales will be completed:
Following the baseline assessments, participants will be provided with the technologies appropriate for their use at home and will be trained in their use. Thereafter, participants will complete 'at-home' assessments, using technologies either independently or with support via video or phone call following a defined schedule. Participants will be asked to use a minimum of 2 suitable technologies, which will be selected by the researchers based on their clinical presentation. Participants will be provided with the option to opt-out of using a technology that they feel it would be overly burdensome for them. Researchers will maintain regular contact with participants, via phone call or video call and will 'check-in' regularly regarding how they are managing with the at-home assessments.
These will include:
Validity of the remote measures and the novel technologies will be assessed by comparing traditional assessment methods to novel methods. After using a technology at least twice, a subset of participants will be invited to complete the System Usability Scale (SUS) questionnaire and a semi-structured interview regarding their experience using the technology. Percentage adherence to the remote monitoring schedule will also be quantified. The study will operate in accordance with data protection legislation (GDPR), the declaration of Helsinki, and with Irish and EU legal and ethical requirement for cyber-protection of sensitive patient data. A data protection impact assessment (DPIA) has been completed and approved by the Beaumont Hospital and Trinity College Dublin ethics boards. Data sharing agreements are also in place for any of the relevant technologies included in the study.
This study is part of a larger research program entitled Precision ALS [www.precisionals.ie]. Precision ALS is a European project which aims to collect large amounts of data about people with MND all over Europe, to make research in ALS/MND more powerful.
Recruitment will primarily take place at the MND clinic in a hospital in Dublin, Ireland (Beaumont Hospital). The national support organisation, the Irish Motor Neurone Disease Association (IMNDA), will also share information about the study including contact details for the research team to their clients through their website and quarterly member's newsletter.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Completion of 12-month follow up period
An adherence percentage will be calculated based on the number of data captures completed by the participant divided by the total target number of data captures multiplied by 100/1.
Time frame: 12 months per participant
System Usability Scale
A system usability scale (SUS) will be carried out on every technology to assess usability with a sample of 15 patients per technology (except the prototype hand grip ergometer which will have a sample of 5 patients). Responses will be collected once for each remote or prototype technology that the participant uses over the course of the study. The participant will have used the technology at least twice prior to collecting feedback and as such this affects the schedule for the SUS interviews. Technologies that are part of the in-person assessments (Index-eTap and Gaitkeeper) will have their SUS interviews scheduled in Month 3 (second in-person visit). All other technologies will have their SUS interviews carried out at least 2/3 uses via a video call and before 5 months. This is to reduce burden on participants.
Time frame: Modality (Month 1), IOPI Trainer (Month 5), Prototype hand grip ergometer (after 2/3 uses), Index-eTap (Month 3), GaitKeeper (Month 3), ActiGraph (Month 3), MIR (Month 5), PCF (Month 3)
Participant withdrawal or death during the study.
Date of withdrawal or death will be recorded. A percentage attrition rate will be calculated based on the number of participants who withdrew or died within the 12-month period divided by the total number of participants who completed baseline functional measures multiplied by 100/1
Time frame: Less than 12 months depending on date of participant withdrawal or death.
Semi-structured interview on usability
Semi-structured interviews on usability will be carried out on every technology to assess usability with a sample of 15 patients per technology (except the prototype hand grip ergometer which will have a sample of 5 patients). Responses will be collected once for each remote or prototype technology that the participant uses over the course of the study. The participant will have used the technology at least twice prior to collecting feedback and as such this affects the schedule for the interviews. Technologies that are part of the in-person assessments (Index-eTap and Gaitkeeper) will have their interviews scheduled in Month 3 (second in-person visit). All other technologies will have their interviews carried out at least 2/3 uses via a video call and before 5 months. This is to reduce burden on participants.
Time frame: Modality (Month 1), IOPI Trainer (Month 5), Prototype hand grip ergometer (after 2/3 uses), Index-eTap (Month 3), GaitKeeper (Month 3), ActiGraph (Month 3), MIR (Month 5), PCF (Month 3)
Plan to share: No — Data will only be analysed by researchers within the Precision ALS partnership within their host institutions in coordination with the local and overall PIs. Data analysis permissions are also governed by the inter-institutional agreement.
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Jun 2027, 30 months after the start.
Of 127 non-industry observational studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 125. This study's planned 30 months is below that.
Counting every sponsor, half of 136 studies reached it within 64 months; a quarter within 29 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
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Amyotrophic Lateral Sclerosis →
University of Dublin, Trinity College