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Enrolling by invitation NCT07582653

OCTive: A New Horizon in MS Digital Solution

Observational Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Primary outcome measures

  • Agreement and reliability between DigiBalance quantitative physical function metrics and standard clinical assessments [Time frame: Baseline]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • University of Exeter Engineering Research Centre — Exeter

Identifiers

NCT: NCT07582653 · 67269

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗