Multiple SclerosisNCT07582653
OCTive: A New Horizon in MS Digital Solution
An observational study of Multiple Sclerosis, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Multiple Sclerosis (MS) is a condition that affects the brain and spinal cord, leading to problems with movement, balance, and vision. This project will validate innovative tools developed for monitoring MS progression using advanced movement analysis and retinal imaging technologies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2026to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with Multiple Sclerosis
Who may be able to join
- condition has been stable over a period of a month
- can walk at least 10 metres independently with or without their walking aids
Who cannot join
- pregnancy
- allergic to adhesive materials
- a condition that precludes safe participation in the assessment as indicated by the referring clinician
- insufficient mental capacity to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Exeter Engineering Research Centre
Exeter, Devon, EX5 2FN
About this study
Official title: Measuring Motor Symptoms in Clinical Conditions OR Objective Measures to Monitor the Progression of Motor Symptoms of Clinical Conditions
Multiple Sclerosis (MS) is a condition that affects the brain and spinal cord, leading to problems with movement, balance, and vision. This project will validate innovative tools developed for monitoring MS progression using advanced movement analysis and retinal imaging technologies. Two computer vision-based applications, Digi Motion and Digi Balance, will measure range of motion, centre of mass, balance, and stability. In parallel, a model will be trained to analyse eye images using Optical Coherence Tomography (OCT)-a non-invasive technique that captures detailed views of retinal structures, including the retinal nerve fibre layer (RNFL), ganglion cell-inner plexiform layer (GC-IPL), and macular thickness, which are key biomarkers of MS-related neuroaxonal loss.
These tools will be evaluated in people with MS, comparing results with traditional clinical assessments to determine reliability and validity. By integrating movement and retinal biomarkers, this approach aims to create a comprehensive and personalised method for tracking disease progression.
Read the detailed description
clinical investigation
- Conditions
- Multiple Sclerosis
- Keywords
- Movement analysis, Artificial Intelligence (AI)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with multiple sclerosis | This cohort consists of individuals diagnosed with multiple sclerosis. No interventions are administered as part of this study; participants will undergo non-invasive assessments and data collection only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement and reliability between DigiBalance quantitative physical function metrics and standard clinical assessments
The researchers are seeking to establish proof of concept through comparison of the data gathered by DigiBalance, with that gathered by the current standard assessment tool, the Expanded Disability Status Scale (EDSS) used to quantify disability in multiple sclerosis (MS). The level of agreement, and therefore the reliability, will be assessed by comparison of the quantitative measures obtained from the DigiBalance digital assessment tool (which captures range of motion, centre of mass displacement, stability index) and corresponding standard clinical assessments of physical function. Additionally the level of agreement between OCT-based retinal measurements (e.g., RNFL thickness, GC IPL thickness, macular thickness) and standard ophthalmic assessments.
Agreement will be quantified using Intraclass Correlation Coefficients (ICC) and Bland-Altman limits of agreement.
Measured: Baseline
Secondary outcomes (3)
Feasibility of the practicality of conducting the integrated digital assessment battery within a laboratory setting
Assessment of the practicality of conducting the integrated digital assessment battery within a laboratory setting through the success rate. The success rate of completing each component of the assessment will be calculated as follows - the number of participants who completed the assessment divided by the total number of participants to attempt the the assessment.
Measured: Baseline
Feasibility of the practicality of conducting the integrated digital assessment battery within a laboratory setting
Assessment of the practicality of conducting the integrated digital assessment battery within a laboratory setting through the time taken for each component of the OCTive assessment to be completed, for each participant. The unit of measure will be minutes. Technical challenges will also be noted by staff.
Measured: Baseline
Usability of the interfaces, comfort, and clarity of instructions
Qualitative feedback from participants regarding their experience with DigiBalance, and OCT-based methods. This feedback will focus on the usability of the interfaces, comfort, and clarity of instructions, and will be gathered through Patient and Public Involvement and Engagement (PPIE) activities. Feedback will be captured using qualitative measures.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Feb 2026
- Primary completion31 Mar 2026
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Brookes University
- Responsible party
- Sponsor
- Investigators
- Mae Mansoubi, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582653
- Sponsor's protocol ID
- 67269
- Status last verified
- May 2026
- First submitted
- 2 Feb 2026
- Last updated
- 13 May 2026
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Motor Symptoms in Clinical Conditions OR Objective Measures to Monitor the Progression of Motor Symptoms of Clinical Conditions
- ClinicalTrials.gov ID
- NCT07582653
- Acronym / sponsor ID
- 67269
- Conditions
- Multiple Sclerosis
- Keywords
- Movement analysis, Artificial Intelligence (AI)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Oxford Brookes University
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 13 May 2026 (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.
Multiple Sclerosis (MS) is a condition that affects the brain and spinal cord, leading to problems with movement, balance, and vision. This project will validate innovative tools developed for monitoring MS progression using advanced movement analysis and retinal imaging technologies. Two computer vision-based applications, Digi Motion and Digi Balance, will measure range of motion, centre of mass, balance, and stability. In parallel, a model will be trained to analyse eye images using Optical Coherence Tomography (OCT)-a non-invasive technique that captures detailed views of retinal structures, including the retinal nerve fibre layer (RNFL), ganglion cell-inner plexiform layer (GC-IPL), and macular thickness, which are key biomarkers of MS-related neuroaxonal loss.
These tools will be evaluated in people with MS, comparing results with traditional clinical assessments to determine reliability and validity. By integrating movement and retinal biomarkers, this approach aims to create a comprehensive and personalised method for tracking disease progression.
Detailed description
clinical investigation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with multiple sclerosis | – | –This cohort consists of individuals diagnosed with multiple sclerosis. No interventions are administered as part of this study; participants will undergo non-invasive assessments and data collection only. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Multiple Sclerosis
Key inclusion criteria (2 listed)
- condition has been stable over a period of a month
- can walk at least 10 metres independently with or without their walking aids
Key exclusion criteria (4 listed)
- pregnancy
- allergic to adhesive materials
- a condition that precludes safe participation in the assessment as indicated by the referring clinician
- insufficient mental capacity to consent
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
Agreement and reliability between DigiBalance quantitative physical function metrics and standard clinical assessments
Time frame: Baseline
The researchers are seeking to establish proof of concept through comparison of the data gathered by DigiBalance, with that gathered by the current standard assessment tool, the Expanded Disability Status Scale (EDSS) used to quantify disability in multiple sclerosis (MS). The level of agreement, and therefore the reliability, will be assessed by comparison of the quantitative measures obtained from the DigiBalance digital assessment tool (which captures range of motion, centre of mass displacement, stability index) and corresponding standard clinical assessments of physical function. Additionally the level of agreement between OCT-based retinal measurements (e.g., RNFL thickness, GC IPL thickness, macular thickness) and standard ophthalmic assessments. Agreement will be quantified using Intraclass Correlation Coefficients (ICC) and Bland-Altman limits of agreement.
3 secondary outcomes
Feasibility of the practicality of conducting the integrated digital assessment battery within a laboratory setting
Time frame: Baseline
Feasibility of the practicality of conducting the integrated digital assessment battery within a laboratory setting
Time frame: Baseline
Usability of the interfaces, comfort, and clarity of instructions
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- 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.
Mae Mansoubi, PhD principal investigator
University of Exeter
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 Multiple Sclerosis, run by University of Exeter at 1 site in United Kingdom.
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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 13 May 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Agreement and reliability between DigiBalance quantitative physical function metrics and standard clinical assessments (time frame: Baseline). 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 13 May 2026.