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OpenTrials
Enrolling by Invitation

NCT Number: NCT07582653

OCTive: A New Horizon in MS Digital Solution

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Exeter Engineering Research Centre

Exeter, Devon, EX5 2FN, United Kingdom

About this study

clinical investigation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Oxford Brookes University

Registry information

Official study title

Measuring Motor Symptoms in Clinical Conditions OR Objective Measures to Monitor the Progression of Motor Symptoms of Clinical Conditions

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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