ClinicalTrials.gg
Enrolling by invitationNCT07582653Updated May 13, 2026

OCTive: A New Horizon in MS Digital Solution

An observational study in Multiple Sclerosis, sponsored by University of Exeter. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by University of Exeter · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Multiple Sclerosis

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Keywords

  • Movement analysis
  • Artificial Intelligence (AI)
03

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's planned enrollment of 10 is below the median of 100 across 970 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of Exeter is the lead sponsor of 140 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants with Multiple Sclerosis

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.

Inclusion criteria

  • condition has been stable over a period of a month
  • can walk at least 10 metres independently with or without their walking aids

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

07

Study locations

1 site
  • University of Exeter Engineering Research Centre
    Exeter, Devon EX5 2FN, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2026 to primary completion in Mar 2026, 1 month.

Of 334 non-industry observational studies under Multiple Sclerosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 73. This study's 1 month is below that.

Counting every sponsor, half of 425 studies reached it within 41 months; a quarter within 15 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2026
First posted
May 13, 2026
StartActual
Feb 1, 2026
Primary completionActual
Mar 31, 2026
CompletionEst.
May 31, 2026
Last update
May 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07582653
Collaborators
Oxford Brookes University
Responsible party
Sponsor
First posted
May 13, 2026
Start date
Feb 1, 2026
Primary completion
Mar 31, 2026
Completion
May 31, 2026 (estimated)
Last update
May 13, 2026

Study contacts

Mae Mansoubi, PhD
principal investigator · University of Exeter

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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