OCTive: A New Horizon in MS Digital Solution

May 5, 2026 updated by: University of Exeter

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

clinical investigation

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with Multiple Sclerosis

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the practicality of conducting the integrated digital assessment battery within a laboratory setting
Time Frame: Baseline
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.
Baseline
Feasibility of the practicality of conducting the integrated digital assessment battery within a laboratory setting
Time Frame: Baseline
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.
Baseline
Usability of the interfaces, comfort, and clarity of instructions
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Exeter

Collaborators

Oxford Brookes University

Investigators

  • Principal Investigator: Mae Mansoubi, PhD, University of Exeter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Actual)

March 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67269

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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