OCTive: A New Horizon in MS Digital Solution

NCT07582653 | Enrolling By Invitation

• 1 other identifier: 67269
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Movement analysis; Artificial Intelligence (AI)

Outcome Measures

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.

  Baseline

Secondary Outcomes (3)

• Feasibility of the practicality of conducting the integrated digital assessment battery within a laboratory setting

  Baseline

• Feasibility of the practicality of conducting the integrated digital assessment battery within a laboratory setting

  Baseline

• Usability of the interfaces, comfort, and clarity of instructions

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Multiple Sclerosis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• Oxford Brookes University: collaborator

Study Sites (1)

University of Exeter Engineering Research Centre

Exeter, Devon, EX5 2FN, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mae Mansoubi, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: May 13, 2026
• Study Start: February 1, 2026
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)